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Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

Primary Purpose

COPD

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Glycopyrronium

SABA

LABA

Indacaterol maleate and glycopyrronium bromide

LAMA

SAMA

ICS

About this trial

This is an interventional treatment trial for COPD focused on measuring Moderate COPD, glycopyrronium bromide, indacaterol maleate and glycopyrronium bromide FDC, NVA237, QVA149

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female adults aged ≥ 40 years
Patients with moderate COPD according to the GOLD criteria 2013
Current or ex-smokers who have a smoking history of at least 10 pack years
Patients with airflow limitation indicated by a postbronchodilator FEV1 ≥50% and <80% of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7 at Visit 2. Post- bronchodilator refers to within 10-15 min of inhalation of 400 μg (4x100 μg) of salbutamol
Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline treatments: *Any SABA monotherapy (such as, but not limited to, salbutamol) *Any SAMA monotherapy (such as, but not limited to, ipratropium) *Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium) *Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol) *Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237) *Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide).
Patients with an mMRC score ≥1 at Visit 1.

Exclusion Criteria:

Patients with conditions contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or to drugs of similar chemical classes or any component thereof: Anti-cholinergic agents, Long- and short-acting 2-adrenergic agonists, Sympathomimetic amines, Lactose or any of the other excipients of the trial medication.
Patients with narrow-angle glaucoma or urinary retention, severe renal impairment (history of estimated glomerular filtration rate below 30 ml/min/1.73 m2 within 12 months prior to visit 1), including those with end-stage renal disease requiring dialysis.
Patients with active/ clinical history of asthma.If the Investigator finds clear and compelling evidence that a patient was misdiagnosed with asthma in the past, then the burden of proof is on the Investigator to properly document this previous misdiagnosis. This documentation must include the rationale for this change in diagnosis including reference to the differential diagnosis that supports this decision.
Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Patients who have a post-bronchodilator FEV1 decrease more than 10% compared to pre-bronchodilator FEV1 result at Visit 2 (see Appendix 5 for details).
A documented history of >1 COPD exacerbation requiring treatment with systemic corticosteroids or antibiotics and/or hospitalization in the previous 12 months.
Patients who have NOT had a COPD exacerbation in the previous 12 months and develop a COPD exacerbation between screening (Visit 1) and (Visit 2) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. (Patients suffering an exacerbation between Visit 1 and Visit 2 can only be re-screened in case it is the first one in the previous 12 months. In case this COPD exacerbation has led to an alteration of the patient COPD treatment, before this patient can be re-screened 3 months of stable COPD treatment will be required as described in Inclusion Criterion 6).
Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to): *Unstable ischemic heart disease, left ventricular failure (NYHA Class III & IV), history of myocardial infarction,arrhythmia (excluding chronic stable atrial fibrillation). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study.*Uncontrolled hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state. *Any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
History of resting QTc (Fridericia preferred, but Bazett acceptable) >450 msec (male) or >460 msec (female) within five years before Visit 1.
Patients who are treated with glycopyrronium bromide (NVA237) at visit 1 are not allowed to be included into the trialPatients on non-selective beta-blockers. Those patients may enter the study after non-selective beta-blocker withdrawal during a 7-day wash-out period.
Patients receiving any other prohibited COPD-related medications specified in Table 5-2 Prohibited COPD related medications must undergo the required wash-out period prior to Visit 2.
Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
Patients with a body mass index (BMI) of more than 40 kg/m2.
Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

A1 (any SABA and/or SAMA)

A2 (glycopyrronium)

B1 (any LAMA or LABA and mMRC=1)

B2 (glycopyrronium and mMRC=1)

C1 (any LABA and ICS)

C2 (indacaterol/glycopyrronium)

D1 (any LAMA or LABA and mMRC>1)

D2 (indacaterol/glycopyrronium and mMRC>1)

Arm Description

Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) during 90 days of treatment

Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)

Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA

Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)

Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC

Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)

Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA

Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).

Outcomes

Primary Outcome Measures

Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)

Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Secondary Outcome Measures

Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC

Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

Total score of COPD Assessment Test (CAT) will be measured at baseline and at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.

Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

The Clinical COPD Questionnaire (CCQ) is a self-administered 10-item questionnaire developed to measure clinical control in patients with COPD. Patients will be instructed to recall their experiences during the previous week. They respond to each question using a 7-point scale from 0 = asymptomatic/no imitation to 6 = extremely symptomatic/totally limited. The questionnaire is divided into 3 domains (symptoms [items 1, 2, 5, and 6] functional [items 7, 8, 9, and 10] and mental state [items 3 and 4]). The overall clinical COPD control score and the scores of the domains are calculated by adding all the scores together and dividing this sum by the number of questions. Thus, the overall clinical COPD control score as well as the score on each of the three domains varies between 0 (very good control) to 6 (extremely poor control).

Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

Mean number of puffs of rescue medication use will be measured using eDiary data over 12 weeks of treatment.

Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

Patient-reported symptoms of COPD combined will be measured using eDiary data reported over the 12 week treatment period. The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of nights with no nighttime awakenings and percentage of days with no symptoms.

Full Information

NCT ID

NCT01985334

First Posted

November 4, 2013

Last Updated

March 18, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01985334

Brief Title

Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

Official Title

A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

February 14, 2014 (Actual)

Primary Completion Date

April 29, 2016 (Actual)

Study Completion Date

April 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

Detailed Description

The treatment epoch will last 12 weeks. The total duration of the study for each patient is 12 weeks (from randomization) plus 30 days of safety follow-up. The study has three phases: screening phase (=wash-out period, if required), treatment phase and safety follow-up phase. Eligible patients will be randomized to either receive glycopyrronium or indacaterol maleate and glycopyrronium bromide fixed dose combination or to remain in their baseline therapy, in an allocation ratio of 3:1 for each cluster (Groups A, B, C, and D), based on their COPD symptoms and baseline treatment: Group A: Patients treated with any SABA ( Short-acting β2-adrenergic agonist) and/or SAMA (Short-acting muscarinic antagonist) as monotherapy or in free or fixed dose combination (FDC) will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group B: Patients treated with any LABA (Long-acting β2-adrenergic agonist) or LAMA (Long-acting muscarinic antagonist) monotherapy and mMRC score =1 point will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group C: Patients treated with any LABA and ICS (Inhaled corticosteroid) in free or FDC will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Group D: Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Due to low recruitment in Groups A and B that would lead to a significant delay of trial completion, a protocol amendment was made in order to close the recruitment of Groups A and B at the time the randomization in Groups C and D would be completed. Recruitment of the Groups C and D continued as originally planned

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD

Keywords

Moderate COPD, glycopyrronium bromide, indacaterol maleate and glycopyrronium bromide FDC, NVA237, QVA149

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4389 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A1 (any SABA and/or SAMA)

Arm Type

Experimental

Arm Description

Arm Title

A2 (glycopyrronium)

Arm Type

Experimental

Arm Description

Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)

Arm Title

B1 (any LAMA or LABA and mMRC=1)

Arm Type

Experimental

Arm Description

Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA

Arm Title

B2 (glycopyrronium and mMRC=1)

Arm Type

Experimental

Arm Description

Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)

Arm Title

C1 (any LABA and ICS)

Arm Type

Experimental

Arm Description

Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC

Arm Title

C2 (indacaterol/glycopyrronium)

Arm Type

Experimental

Arm Description

Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)

Arm Title

D1 (any LAMA or LABA and mMRC>1)

Arm Type

Experimental

Arm Description

Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA

Arm Title

D2 (indacaterol/glycopyrronium and mMRC>1)

Arm Type

Experimental

Arm Description

Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).

Intervention Type

Drug

Intervention Name(s)

Glycopyrronium

Other Intervention Name(s)

glycopyrronium bromide

Intervention Description

Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day

Intervention Type

Drug

Intervention Name(s)

SABA

Intervention Description

Short-acting β2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy

Intervention Type

Drug

Intervention Name(s)

LABA

Intervention Description

Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy

Intervention Type

Drug

Intervention Name(s)

Indacaterol maleate and glycopyrronium bromide

Intervention Description

Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day

Intervention Type

Drug

Intervention Name(s)

LAMA

Intervention Description

Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy

Intervention Type

Drug

Intervention Name(s)

SAMA

Intervention Description

Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy

Intervention Type

Drug

Intervention Name(s)

ICS

Intervention Description

Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy

Primary Outcome Measure Information:

Title

Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)

Description

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

Time Frame

Week 12 (Visit 4)

Title

Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Description

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

Time Frame

Week 12 (Visit 4)

Title

Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC

Description

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

Time Frame

Week 12 (Visit 4)

Title

Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Description

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

Time Frame

Week 12 (Visit 4)

Title

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)

Description

Time Frame

Day 1 (baseline) and week 12

Title

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Description

Time Frame

Day 1 (baseline) and week 12

Title

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC

Description

Time Frame

Day 1 (baseline) and week 12

Title

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Description

Time Frame

Day 1 (baseline) and week 12

Secondary Outcome Measure Information:

Title

Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

Description

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

Time Frame

12 Weeks

Title

Description

Time Frame

Day 1 (baseline) and week 12

Title

Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.

Description

Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

Time Frame

12 Weeks

Title

Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC

Description

Time Frame

Day 1 (baseline) and week 12

Title

Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

Description

Time Frame

Day 1 (baseline) and Week 12

Title

Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

Description

Time Frame

Day 1 (baseline) and Week 12

Title

Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

Description

Mean number of puffs of rescue medication use will be measured using eDiary data over 12 weeks of treatment.

Time Frame

12 weeks

Title

Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

Description

Time Frame

Baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female adults aged ≥ 40 years Patients with moderate COPD according to the GOLD criteria 2013 Current or ex-smokers who have a smoking history of at least 10 pack years Patients with airflow limitation indicated by a postbronchodilator FEV1 ≥50% and <80% of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7 at Visit 2. Post- bronchodilator refers to within 10-15 min of inhalation of 400 μg (4x100 μg) of salbutamol Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline treatments: *Any SABA monotherapy (such as, but not limited to, salbutamol) *Any SAMA monotherapy (such as, but not limited to, ipratropium) *Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium) *Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol) *Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237) *Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide). Patients with an mMRC score ≥1 at Visit 1. Exclusion Criteria: Patients with conditions contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or to drugs of similar chemical classes or any component thereof: Anti-cholinergic agents, Long- and short-acting 2-adrenergic agonists, Sympathomimetic amines, Lactose or any of the other excipients of the trial medication. Patients with narrow-angle glaucoma or urinary retention, severe renal impairment (history of estimated glomerular filtration rate below 30 ml/min/1.73 m2 within 12 months prior to visit 1), including those with end-stage renal disease requiring dialysis. Patients with active/ clinical history of asthma.If the Investigator finds clear and compelling evidence that a patient was misdiagnosed with asthma in the past, then the burden of proof is on the Investigator to properly document this previous misdiagnosis. This documentation must include the rationale for this change in diagnosis including reference to the differential diagnosis that supports this decision. Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. Patients who have a post-bronchodilator FEV1 decrease more than 10% compared to pre-bronchodilator FEV1 result at Visit 2 (see Appendix 5 for details). A documented history of >1 COPD exacerbation requiring treatment with systemic corticosteroids or antibiotics and/or hospitalization in the previous 12 months. Patients who have NOT had a COPD exacerbation in the previous 12 months and develop a COPD exacerbation between screening (Visit 1) and (Visit 2) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. (Patients suffering an exacerbation between Visit 1 and Visit 2 can only be re-screened in case it is the first one in the previous 12 months. In case this COPD exacerbation has led to an alteration of the patient COPD treatment, before this patient can be re-screened 3 months of stable COPD treatment will be required as described in Inclusion Criterion 6). Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to): *Unstable ischemic heart disease, left ventricular failure (NYHA Class III & IV), history of myocardial infarction,arrhythmia (excluding chronic stable atrial fibrillation). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study.*Uncontrolled hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state. *Any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study History of resting QTc (Fridericia preferred, but Bazett acceptable) >450 msec (male) or >460 msec (female) within five years before Visit 1. Patients who are treated with glycopyrronium bromide (NVA237) at visit 1 are not allowed to be included into the trialPatients on non-selective beta-blockers. Those patients may enter the study after non-selective beta-blocker withdrawal during a 7-day wash-out period. Patients receiving any other prohibited COPD-related medications specified in Table 5-2 Prohibited COPD related medications must undergo the required wash-out period prior to Visit 2. Patients who are, in the opinion of the investigator known to be unreliable or non-compliant. Patients with a body mass index (BMI) of more than 40 kg/m2. Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Amstetten

ZIP/Postal Code

3300

Country

Austria

Facility Name

Novartis Investigative Site

City

Feldkirch

ZIP/Postal Code

6800

Country

Austria

Facility Name

Novartis Investigative Site

City

Hallein

ZIP/Postal Code

5400

Country

Austria

Facility Name

Novartis Investigative Site

City

Kirchdorf an der Krems

ZIP/Postal Code

4560

Country

Austria

Facility Name

Novartis Investigative Site

City

Leoben

ZIP/Postal Code

8700

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Perg

ZIP/Postal Code

4320

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Gosselies

State/Province

BEL

ZIP/Postal Code

6041

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gozee

State/Province

BEL

ZIP/Postal Code

6534

Country

Belgium

Facility Name

Novartis Investigative Site

City

Zichem

State/Province

BEL

ZIP/Postal Code

3271

Country

Belgium

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Balen

ZIP/Postal Code

2490

Country

Belgium

Facility Name

Novartis Investigative Site

City

Braine l'Alleud

ZIP/Postal Code

1420

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Eghezee

ZIP/Postal Code

5310

Country

Belgium

Facility Name

Novartis Investigative Site

City

Erpent

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Geraardsbergen

ZIP/Postal Code

9500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Halen

ZIP/Postal Code

3545

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Heusy

ZIP/Postal Code

4802

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ieper

ZIP/Postal Code

8900

Country

Belgium

Facility Name

Novartis Investigative Site

City

Knokke-Heist

ZIP/Postal Code

8300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Lebbeke

ZIP/Postal Code

9280

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Maaseik

ZIP/Postal Code

3680

Country

Belgium

Facility Name

Novartis Investigative Site

City

Malmedy

ZIP/Postal Code

4960

Country

Belgium

Facility Name

Novartis Investigative Site

City

Mechelen

ZIP/Postal Code

2800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Melsbroek

ZIP/Postal Code

1820

Country

Belgium

Facility Name

Novartis Investigative Site

City

Merksem

ZIP/Postal Code

2170

Country

Belgium

Facility Name

Novartis Investigative Site

City

Montegnée

ZIP/Postal Code

4420

Country

Belgium

Facility Name

Novartis Investigative Site

City

Natoye

ZIP/Postal Code

5360

Country

Belgium

Facility Name

Novartis Investigative Site

City

Paal-Beringen

ZIP/Postal Code

3583

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ronse

ZIP/Postal Code

9600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Saint-Medard

ZIP/Postal Code

6887

Country

Belgium

Facility Name

Novartis Investigative Site

City

Seraing

ZIP/Postal Code

4100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Tournai

ZIP/Postal Code

7500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Verviers

ZIP/Postal Code

4800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Vilvoorde

ZIP/Postal Code

1800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Zottegem

ZIP/Postal Code

9620

Country

Belgium

Facility Name

Novartis Investigative Site

City

Boskovice

State/Province

Czech Republic

ZIP/Postal Code

680 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brandys Nad Labem

State/Province

Czech Republic

ZIP/Postal Code

25001

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno-Kralovo Pole

State/Province

Czech Republic

ZIP/Postal Code

61200

Country

Czechia

Facility Name

Novartis Investigative Site

City

Cvikov

State/Province

Czech Republic

ZIP/Postal Code

471 54

Country

Czechia

Facility Name

Novartis Investigative Site

City

Havlickuv Brod

State/Province

Czech Republic

ZIP/Postal Code

580 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Jirkov

State/Province

Czech Republic

ZIP/Postal Code

43111

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kurim

State/Province

Czech Republic

ZIP/Postal Code

66434

Country

Czechia

Facility Name

Novartis Investigative Site

City

Liberec

State/Province

Czech Republic

ZIP/Postal Code

460 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Lovosice

State/Province

Czech Republic

ZIP/Postal Code

410 02

Country

Czechia

Facility Name

Novartis Investigative Site

City

Neratovice

State/Province

Czech Republic

ZIP/Postal Code

27711

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava

State/Province

Czech Republic

ZIP/Postal Code

708 68

Country

Czechia

Facility Name

Novartis Investigative Site

City

Pardubice

State/Province

Czech Republic

ZIP/Postal Code

530 09

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

State/Province

Czech Republic

ZIP/Postal Code

33011

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

State/Province

Czech Republic

ZIP/Postal Code

331 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 4

State/Province

Czech Republic

ZIP/Postal Code

142 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague

State/Province

Czech Republic

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

State/Province

Czech Republic

ZIP/Postal Code

108 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 4

State/Province

Czech Republic

ZIP/Postal Code

140 46

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 6

State/Province

Czech Republic

ZIP/Postal Code

163 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 9

State/Province

Czech Republic

ZIP/Postal Code

19000

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

State/Province

Czech Republic

ZIP/Postal Code

14800

Country

Czechia

Facility Name

Novartis Investigative Site

City

Rokycany

State/Province

Czech Republic

ZIP/Postal Code

337 22

Country

Czechia

Facility Name

Novartis Investigative Site

City

Rudna

State/Province

Czech Republic

ZIP/Postal Code

25219

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

Czech Republic

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Trebic

State/Province

Czech Republic

ZIP/Postal Code

674 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Varnsdorf

State/Province

Czech Republic

ZIP/Postal Code

40747

Country

Czechia

Facility Name

Novartis Investigative Site

City

Zatec

State/Province

Czech Republic

ZIP/Postal Code

438 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Znojmo

State/Province

Czech Republic

ZIP/Postal Code

672 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 8

ZIP/Postal Code

182 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Alleroed

ZIP/Postal Code

3450

Country

Denmark

Facility Name

Novartis Investigative Site

City

Greve

ZIP/Postal Code

2670

Country

Denmark

Facility Name

Novartis Investigative Site

City

Haslev

ZIP/Postal Code

4690

Country

Denmark

Facility Name

Novartis Investigative Site

City

Søborg

ZIP/Postal Code

2860

Country

Denmark

Facility Name

Novartis Investigative Site

City

Værløse

ZIP/Postal Code

3500

Country

Denmark

Facility Name

Novartis Investigative Site

City

Paide

ZIP/Postal Code

72714

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13619

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tours Cedex 9

State/Province

Indre Et Loire

ZIP/Postal Code

37044

Country

France

Facility Name

Novartis Investigative Site

City

Briis Sous Forges

ZIP/Postal Code

91640

Country

France

Facility Name

Novartis Investigative Site

City

Chamalieres

ZIP/Postal Code

63400

Country

France

Facility Name

Novartis Investigative Site

City

Chatellerault

ZIP/Postal Code

86100

Country

France

Facility Name

Novartis Investigative Site

City

Forbach

ZIP/Postal Code

57600

Country

France

Facility Name

Novartis Investigative Site

City

L'Aigle

ZIP/Postal Code

61305

Country

France

Facility Name

Novartis Investigative Site

City

La Bouexiere

ZIP/Postal Code

35340

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13003

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34080

Country

France

Facility Name

Novartis Investigative Site

City

Murs Erigne

ZIP/Postal Code

49610

Country

France

Facility Name

Novartis Investigative Site

City

Nice

ZIP/Postal Code

06000

Country

France

Facility Name

Novartis Investigative Site

City

Saint Jean de Luz

ZIP/Postal Code

64500

Country

France

Facility Name

Novartis Investigative Site

City

Saint Laurent Du Var

ZIP/Postal Code

06721

Country

France

Facility Name

Novartis Investigative Site

City

Saint Pierre

ZIP/Postal Code

97448

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Novartis Investigative Site

City

Toulon

ZIP/Postal Code

83000

Country

France

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30159

Country

Germany

Facility Name

Novartis Investigative Site

City

Peine

State/Province

Niedersachsen

ZIP/Postal Code

31224

Country

Germany

Facility Name

Novartis Investigative Site

City

Warendorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48231

Country

Germany

Facility Name

Novartis Investigative Site

City

Koblenz

State/Province

NRW

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

State/Province

Rheinland Pfalz

ZIP/Postal Code

45127

Country

Germany

Facility Name

Novartis Investigative Site

City

Cottbus

State/Province

Sachsen

ZIP/Postal Code

03050

Country

Germany

Facility Name

Novartis Investigative Site

City

Geesthacht

State/Province

Schleswig Holstein

ZIP/Postal Code

12502

Country

Germany

Facility Name

Novartis Investigative Site

City

Annaberg-Buchholz

ZIP/Postal Code

09456

Country

Germany

Facility Name

Novartis Investigative Site

City

Auerbach

ZIP/Postal Code

08209

Country

Germany

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Neustadt

ZIP/Postal Code

97616

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Salzuflen

ZIP/Postal Code

32105

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Woerishofen

ZIP/Postal Code

86825

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Bensheim

ZIP/Postal Code

64625

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10119

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10367

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10625

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12099

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12159

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12165

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12627

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12687

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13057

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13086

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13156

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13187

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13507

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

D-12165

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33617

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53119

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53123

Country

Germany

Facility Name

Novartis Investigative Site

City

Bottrop

ZIP/Postal Code

46240

Country

Germany

Facility Name

Novartis Investigative Site

City

Bruchsal

ZIP/Postal Code

76646

Country

Germany

Facility Name

Novartis Investigative Site

City

Burgwedel

ZIP/Postal Code

30938

Country

Germany

Facility Name

Novartis Investigative Site

City

Daaden

ZIP/Postal Code

57567

Country

Germany

Facility Name

Novartis Investigative Site

City

Dachau

ZIP/Postal Code

85221

Country

Germany

Facility Name

Novartis Investigative Site

City

Deggendorf

ZIP/Postal Code

94469

Country

Germany

Facility Name

Novartis Investigative Site

City

Deggingen

ZIP/Postal Code

73328

Country

Germany

Facility Name

Novartis Investigative Site

City

Delitzsch

ZIP/Postal Code

04509

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44263

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01129

Country

Germany

Facility Name

Novartis Investigative Site

City

Dueren

ZIP/Postal Code

52349

Country

Germany

Facility Name

Novartis Investigative Site

City

Dusseldorf

ZIP/Postal Code

40489

Country

Germany

Facility Name

Novartis Investigative Site

City

Düsseldorf

ZIP/Postal Code

40211

Country

Germany

Facility Name

Novartis Investigative Site

City

Eisenach

ZIP/Postal Code

99817

Country

Germany

Facility Name

Novartis Investigative Site

City

Elsterwerda

ZIP/Postal Code

04910

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45138

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45276

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45277

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45355

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45359

Country

Germany

Facility Name

Novartis Investigative Site

City

Foehren

ZIP/Postal Code

54343

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankenberg (Eder)

ZIP/Postal Code

35066

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt am Main

ZIP/Postal Code

60313

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79104

Country

Germany

Facility Name

Novartis Investigative Site

City

Freudenberg

ZIP/Postal Code

57258

Country

Germany

Facility Name

Novartis Investigative Site

City

Furstenwalde

ZIP/Postal Code

15517

Country

Germany

Facility Name

Novartis Investigative Site

City

Fürstenwalde/Spree

ZIP/Postal Code

15517

Country

Germany

Facility Name

Novartis Investigative Site

City

Garmisch-Partenkirchen

ZIP/Postal Code

82467

Country

Germany

Facility Name

Novartis Investigative Site

City

Gauting

ZIP/Postal Code

82131

Country

Germany

Facility Name

Novartis Investigative Site

City

Gießen

ZIP/Postal Code

35390

Country

Germany

Facility Name

Novartis Investigative Site

City

Gifhorn

ZIP/Postal Code

38518

Country

Germany

Facility Name

Novartis Investigative Site

City

Goch

ZIP/Postal Code

47574

Country

Germany

Facility Name

Novartis Investigative Site

City

Goerlitz

ZIP/Postal Code

02826

Country

Germany

Facility Name

Novartis Investigative Site

City

Gummersbach

ZIP/Postal Code

51343

Country

Germany

Facility Name

Novartis Investigative Site

City

Gütersloh

ZIP/Postal Code

33330

Country

Germany

Facility Name

Novartis Investigative Site

City

Hagen

ZIP/Postal Code

58089

Country

Germany

Facility Name

Novartis Investigative Site

City

Halberstadt

ZIP/Postal Code

38820

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06108

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20357

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22335

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22527

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30163

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30419

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69117

Country

Germany

Facility Name

Novartis Investigative Site

City

Hettstedt

ZIP/Postal Code

06333

Country

Germany

Facility Name

Novartis Investigative Site

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Novartis Investigative Site

City

Hoyerswerda

ZIP/Postal Code

02977

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Jerichow

ZIP/Postal Code

39319

Country

Germany

Facility Name

Novartis Investigative Site

City

Kamen

ZIP/Postal Code

59174

Country

Germany

Facility Name

Novartis Investigative Site

City

Karlsruhe

ZIP/Postal Code

76199

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34117

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Kleve

ZIP/Postal Code

47533

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50668

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

51069

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

51605

Country

Germany

Facility Name

Novartis Investigative Site

City

Köthen

ZIP/Postal Code

06366

Country

Germany

Facility Name

Novartis Investigative Site

City

Landau-Pfalz

ZIP/Postal Code

76829

Country

Germany

Facility Name

Novartis Investigative Site

City

Landsberg

ZIP/Postal Code

86899

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04109

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04207

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04357

Country

Germany

Facility Name

Novartis Investigative Site

City

Leonberg

ZIP/Postal Code

71229

Country

Germany

Facility Name

Novartis Investigative Site

City

Leverkusen

ZIP/Postal Code

51379

Country

Germany

Facility Name

Novartis Investigative Site

City

Limburgerhof

ZIP/Postal Code

67117

Country

Germany

Facility Name

Novartis Investigative Site

City

Loehne

ZIP/Postal Code

32584

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67061

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67067

Country

Germany

Facility Name

Novartis Investigative Site

City

Luedenscheid

ZIP/Postal Code

58507

Country

Germany

Facility Name

Novartis Investigative Site

City

Lübeck

ZIP/Postal Code

23554

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39112

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35033

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

D-35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Mayen

ZIP/Postal Code

56727

Country

Germany

Facility Name

Novartis Investigative Site

City

Meine

ZIP/Postal Code

38527

Country

Germany

Facility Name

Novartis Investigative Site

City

Meissen

ZIP/Postal Code

01662

Country

Germany

Facility Name

Novartis Investigative Site

City

Menden

ZIP/Postal Code

58706

Country

Germany

Facility Name

Novartis Investigative Site

City

Minden

ZIP/Postal Code

32423

Country

Germany

Facility Name

Novartis Investigative Site

City

Mittweida

ZIP/Postal Code

09648

Country

Germany

Facility Name

Novartis Investigative Site

City

Mülheim

ZIP/Postal Code

45468

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

80335

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

80802

Country

Germany

Facility Name

Novartis Investigative Site

City

Münnerstadt

ZIP/Postal Code

97702

Country

Germany

Facility Name

Novartis Investigative Site

City

Neu Isenburg

ZIP/Postal Code

63263

Country

Germany

Facility Name

Novartis Investigative Site

City

Neu-Ulm

ZIP/Postal Code

89231

Country

Germany

Facility Name

Novartis Investigative Site

City

Neunkirchen

ZIP/Postal Code

66539

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuss

ZIP/Postal Code

41462

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuwied

ZIP/Postal Code

56564

Country

Germany

Facility Name

Novartis Investigative Site

City

Northeim

ZIP/Postal Code

37154

Country

Germany

Facility Name

Novartis Investigative Site

City

Nürnberg

ZIP/Postal Code

90443

Country

Germany

Facility Name

Novartis Investigative Site

City

Nürnberg

ZIP/Postal Code

90478

Country

Germany

Facility Name

Novartis Investigative Site

City

Obermichelbach

ZIP/Postal Code

90587

Country

Germany

Facility Name

Novartis Investigative Site

City

Oschatz

ZIP/Postal Code

04758

Country

Germany

Facility Name

Novartis Investigative Site

City

Oschersleben

ZIP/Postal Code

39387

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrueck

ZIP/Postal Code

49074

Country

Germany

Facility Name

Novartis Investigative Site

City

Papenburg

ZIP/Postal Code

26871

Country

Germany

Facility Name

Novartis Investigative Site

City

Passau

ZIP/Postal Code

94032

Country

Germany

Facility Name

Novartis Investigative Site

City

Plauen

ZIP/Postal Code

08523

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14469

Country

Germany

Facility Name

Novartis Investigative Site

City

Prien A. Chiemsee

ZIP/Postal Code

83209

Country

Germany

Facility Name

Novartis Investigative Site

City

Radebeul

ZIP/Postal Code

01445

Country

Germany

Facility Name

Novartis Investigative Site

City

Ratingen

ZIP/Postal Code

40878

Country

Germany

Facility Name

Novartis Investigative Site

City

Raubach

ZIP/Postal Code

56316

Country

Germany

Facility Name

Novartis Investigative Site

City

Reinfeld

ZIP/Postal Code

23858

Country

Germany

Facility Name

Novartis Investigative Site

City

Rheine

ZIP/Postal Code

48431

Country

Germany

Facility Name

Novartis Investigative Site

City

Rodenbach

ZIP/Postal Code

67688

Country

Germany

Facility Name

Novartis Investigative Site

City

Roth

ZIP/Postal Code

91154

Country

Germany

Facility Name

Novartis Investigative Site

City

Rudersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Novartis Investigative Site

City

Rüsselsheim,

ZIP/Postal Code

65428

Country

Germany

Facility Name

Novartis Investigative Site

City

Rüsselsheim

ZIP/Postal Code

65428

Country

Germany

Facility Name

Novartis Investigative Site

City

Saalfeld

ZIP/Postal Code

07318

Country

Germany

Facility Name

Novartis Investigative Site

City

Saarbruecken

ZIP/Postal Code

66111

Country

Germany

Facility Name

Novartis Investigative Site

City

Schleswig

ZIP/Postal Code

24837

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwabach

ZIP/Postal Code

91126

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwedt

ZIP/Postal Code

16303

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwetzingen

ZIP/Postal Code

68723

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

Novartis Investigative Site

City

Sinsheim

ZIP/Postal Code

74889

Country

Germany

Facility Name

Novartis Investigative Site

City

Solingen

ZIP/Postal Code

42651

Country

Germany

Facility Name

Novartis Investigative Site

City

Solingen

ZIP/Postal Code

42665

Country

Germany

Facility Name

Novartis Investigative Site

City

Solingen

ZIP/Postal Code

42697

Country

Germany

Facility Name

Novartis Investigative Site

City

Sonneberg

ZIP/Postal Code

96515

Country

Germany

Facility Name

Novartis Investigative Site

City

Strausberg

ZIP/Postal Code

15344

Country

Germany

Facility Name

Novartis Investigative Site

City

Teuchern

ZIP/Postal Code

06682

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Wardenburg

ZIP/Postal Code

26203

Country

Germany

Facility Name

Novartis Investigative Site

City

Weilheim

ZIP/Postal Code

82362

Country

Germany

Facility Name

Novartis Investigative Site

City

Welzheim

ZIP/Postal Code

73642

Country

Germany

Facility Name

Novartis Investigative Site

City

Westerkappeln

ZIP/Postal Code

49492

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesloch

ZIP/Postal Code

69168

Country

Germany

Facility Name

Novartis Investigative Site

City

Wissen

ZIP/Postal Code

57537

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Woellstein

ZIP/Postal Code

55597

Country

Germany

Facility Name

Novartis Investigative Site

City

Wolfsburg

ZIP/Postal Code

38448

Country

Germany

Facility Name

Novartis Investigative Site

City

Zerbst

ZIP/Postal Code

39261

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Serres

ZIP/Postal Code

GR 62 100

Country

Greece

Facility Name

Novartis Investigative Site

City

Gyor

State/Province

HUN

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szazhalombatta

State/Province

HUN

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Novartis Investigative Site

City

Cegled

ZIP/Postal Code

2700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4026

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hatvan

ZIP/Postal Code

3000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mako

ZIP/Postal Code

6900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mateszalka

ZIP/Postal Code

4700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7635

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

Facility Name

Novartis Investigative Site

City

Tatabanya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

Novartis Investigative Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Novartis Investigative Site

City

County Limerick

ZIP/Postal Code

V94 F858

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin 7

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

DUBLIN 8

Country

Ireland

Facility Name

Novartis Investigative Site

City

Ancona

State/Province

ZIP/Postal Code

60128

Country

Italy

Facility Name

Novartis Investigative Site

City

Avellino

State/Province

ZIP/Postal Code

83100

Country

Italy

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70123

Country

Italy

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Terlizzi

State/Province

ZIP/Postal Code

70038

Country

Italy

Facility Name

Novartis Investigative Site

City

Triggiano

State/Province

ZIP/Postal Code

70019

Country

Italy

Facility Name

Novartis Investigative Site

City

Romano di Lombardia

State/Province

ZIP/Postal Code

24058

Country

Italy

Facility Name

Novartis Investigative Site

City

Feltre

State/Province

ZIP/Postal Code

32032

Country

Italy

Facility Name

Novartis Investigative Site

City

Telese Terme

State/Province

ZIP/Postal Code

82037

Country

Italy

Facility Name

Novartis Investigative Site

City

San Pietro Vernotico

State/Province

ZIP/Postal Code

72027

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Campobasso

State/Province

ZIP/Postal Code

86100

Country

Italy

Facility Name

Novartis Investigative Site

City

Marcianise

State/Province

ZIP/Postal Code

81025

Country

Italy

Facility Name

Novartis Investigative Site

City

Caltanissetta

State/Province

ZIP/Postal Code

93100

Country

Italy

Facility Name

Novartis Investigative Site

City

Saluzzo

State/Province

ZIP/Postal Code

12037

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95100

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95122

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95126

Country

Italy

Facility Name

Novartis Investigative Site

City

Forlì

State/Province

ZIP/Postal Code

47100

Country

Italy

Facility Name

Novartis Investigative Site

City

Foggia

State/Province

ZIP/Postal Code

71100

Country

Italy

Facility Name

Novartis Investigative Site

City

San Severo

State/Province

ZIP/Postal Code

71016

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50122

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16100

Country

Italy

Facility Name

Novartis Investigative Site

City

Livorno

State/Province

ZIP/Postal Code

57124

Country

Italy

Facility Name

Novartis Investigative Site

City

Lodi

State/Province

ZIP/Postal Code

26900

Country

Italy

Facility Name

Novartis Investigative Site

City

Lido di Camaiore

State/Province

ZIP/Postal Code

55041

Country

Italy

Facility Name

Novartis Investigative Site

City

Monza

State/Province

ZIP/Postal Code

20900

Country

Italy

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Nuoro

State/Province

ZIP/Postal Code

08100

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

Facility Name

Novartis Investigative Site

City

Piacenza

State/Province

ZIP/Postal Code

29100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cittadella

State/Province

ZIP/Postal Code

35013

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pordenone

State/Province

ZIP/Postal Code

33170

Country

Italy

Facility Name

Novartis Investigative Site

City

Voghera

State/Province

ZIP/Postal Code

27058

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00128

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00163

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00189

Country

Italy

Facility Name

Novartis Investigative Site

City

Riccione

State/Province

ZIP/Postal Code

47838

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Sondalo

State/Province

ZIP/Postal Code

23035

Country

Italy

Facility Name

Novartis Investigative Site

City

Sassari

State/Province

ZIP/Postal Code

07100

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Novartis Investigative Site

City

Terni

State/Province

ZIP/Postal Code

05100

Country

Italy

Facility Name

Novartis Investigative Site

City

Montebelluna

State/Province

ZIP/Postal Code

31044

Country

Italy

Facility Name

Novartis Investigative Site

City

Vittorio Veneto

State/Province

ZIP/Postal Code

31029

Country

Italy

Facility Name

Novartis Investigative Site

City

Busto Arsizio

State/Province

ZIP/Postal Code

21052

Country

Italy

Facility Name

Novartis Investigative Site

City

Arzignano

State/Province

ZIP/Postal Code

36071

Country

Italy

Facility Name

Novartis Investigative Site

City

Vicenza

State/Province

ZIP/Postal Code

36100

Country

Italy

Facility Name

Novartis Investigative Site

City

Bussolengo

State/Province

ZIP/Postal Code

37012

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

ZIP/Postal Code

10149

Country

Italy

Facility Name

Novartis Investigative Site

City

Balvi

State/Province

LVA

ZIP/Postal Code

4501

Country

Latvia

Facility Name

Novartis Investigative Site

City

Jurmala

State/Province

LVA

ZIP/Postal Code

LV-2015

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

1011

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Novartis Investigative Site

City

Daugavpils

ZIP/Postal Code

LV-5401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Vilnius

State/Province

LTU

ZIP/Postal Code

LT-10207

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

LT-50128

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

State/Province

ZIP/Postal Code

01117

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Alytus

ZIP/Postal Code

LT-62114

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

3007

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Utena

ZIP/Postal Code

LT-28151

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

06122

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Førde

ZIP/Postal Code

6800

Country

Norway

Facility Name

Novartis Investigative Site

City

Kløfta

ZIP/Postal Code

2040

Country

Norway

Facility Name

Novartis Investigative Site

City

Lierskogen

ZIP/Postal Code

3420

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0190

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0953

Country

Norway

Facility Name

Novartis Investigative Site

City

Skedsmokorset

ZIP/Postal Code

2020

Country

Norway

Facility Name

Novartis Investigative Site

City

Skien

ZIP/Postal Code

3734

Country

Norway

Facility Name

Novartis Investigative Site

City

Stavanger

ZIP/Postal Code

4005

Country

Norway

Facility Name

Novartis Investigative Site

City

Tananger

ZIP/Postal Code

4056

Country

Norway

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-024

Country

Poland

Facility Name

Novartis Investigative Site

City

Nowy Dwor Mazowiecki

ZIP/Postal Code

05-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Ostrow Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Novartis Investigative Site

City

Pila

ZIP/Postal Code

64-920

Country

Poland

Facility Name

Novartis Investigative Site

City

Sopot

ZIP/Postal Code

81-741

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

01-138

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-162

Country

Poland

Facility Name

Novartis Investigative Site

City

Aveiro

ZIP/Postal Code

3814-501

Country

Portugal

Facility Name

Novartis Investigative Site

City

Barcelos

ZIP/Postal Code

4754-909

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3041-853

Country

Portugal

Facility Name

Novartis Investigative Site

City

Guimarães

ZIP/Postal Code

4835-044

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1169-024

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1349-019

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200 319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Franca de Xira

ZIP/Postal Code

2600-009

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Nova de Gaia

ZIP/Postal Code

440-230

Country

Portugal

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 3

ZIP/Postal Code

030303

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

State/Province

Jud. Iasi

ZIP/Postal Code

700115

Country

Romania

Facility Name

Novartis Investigative Site

City

Bacau

ZIP/Postal Code

600252

Country

Romania

Facility Name

Novartis Investigative Site

City

Bragadiru

ZIP/Postal Code

077025

Country

Romania

Facility Name

Novartis Investigative Site

City

Constanta

ZIP/Postal Code

900591

Country

Romania

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Novartis Investigative Site

City

Ramnicu Valcea

ZIP/Postal Code

240564

Country

Romania

Facility Name

Novartis Investigative Site

City

Suceava

ZIP/Postal Code

720284

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

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300736

Country

Romania

Facility Name

Novartis Investigative Site

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Chelyabinsk

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454021

Country

Russian Federation

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Kazan

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420012

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Russian Federation

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Novartis Investigative Site

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Kemerovo

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650029

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Russian Federation

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Moscow

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101990

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Russian Federation

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Novartis Investigative Site

City

Moscow

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125315

Country

Russian Federation

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Novartis Investigative Site

City

N.Novgorod

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603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

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Novosibirsk

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630099

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Novartis Investigative Site

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Saint Petersburg

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197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

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410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

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Smolensk

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214019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

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194354

Country

Russian Federation

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Novartis Investigative Site

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Tomsk

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634050

Country

Russian Federation

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Novartis Investigative Site

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Ufa

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450000

Country

Russian Federation

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Novartis Investigative Site

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Yaroslavl

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150003

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Russian Federation

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Novartis Investigative Site

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Bardejov

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Slovak Republic

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085 01

Country

Slovakia

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Novartis Investigative Site

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Bojnice

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Slovak Republic

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Country

Slovakia

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Liptovsky Hradok

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Slovak Republic

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033 01

Country

Slovakia

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Námestovo

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Slovensko

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02901

Country

Slovakia

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Kralovsky Chlmec

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Levice

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Slovakia

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Poprad

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Country

Slovakia

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Presov

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080 01

Country

Slovakia

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Presov

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08001

Country

Slovakia

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Novartis Investigative Site

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Sala

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927 01

Country

Slovakia

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Novartis Investigative Site

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Sturovo

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943 11

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trnava

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917 75

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Vrable

ZIP/Postal Code

95201

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Golnik

ZIP/Postal Code

4204

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Kranj

ZIP/Postal Code

4000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Murska Sobota

ZIP/Postal Code

9000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Marbella

State/Province

Andalucia

ZIP/Postal Code

29600

Country

Spain

Facility Name

Novartis Investigative Site

City

Marbella

State/Province

Andalucia

ZIP/Postal Code

29603

Country

Spain

Facility Name

Novartis Investigative Site

City

Málaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08917

Country

Spain

Facility Name

Novartis Investigative Site

City

Centelles

State/Province

Barcelona

ZIP/Postal Code

08540

Country

Spain

Facility Name

Novartis Investigative Site

City

Mataro

State/Province

Barcelona

ZIP/Postal Code

08303

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Joan Despi

State/Province

Barcelona

ZIP/Postal Code

08970

Country

Spain

Facility Name

Novartis Investigative Site

City

Vic

State/Province

Barcelona

ZIP/Postal Code

08500

Country

Spain

Facility Name

Novartis Investigative Site

City

Ponferrada

State/Province

Castilla Y Leon

ZIP/Postal Code

24400

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Canet de Mar

State/Province

Cataluna

ZIP/Postal Code

08360

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Boi de Llobregat

State/Province

Cataluna

ZIP/Postal Code

08830

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Vic

State/Province

Cataluña

ZIP/Postal Code

08500

Country

Spain

Facility Name

Novartis Investigative Site

City

Alzira

State/Province

Comunidad Valenciana

ZIP/Postal Code

46600

Country

Spain

Facility Name

Novartis Investigative Site

City

Benidorm

State/Province

Comunidad Valenciana

ZIP/Postal Code

03501

Country

Spain

Facility Name

Novartis Investigative Site

City

Puerto De Sagunto

State/Province

Comunidad Valenciana

ZIP/Postal Code

46520

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46015

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46017

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46019

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceres

State/Province

Extremadura

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

Merida

State/Province

Extremadura

ZIP/Postal Code

06800

Country

Spain

Facility Name

Novartis Investigative Site

City

Motril

State/Province

Granada

ZIP/Postal Code

18600

Country

Spain

Facility Name

Novartis Investigative Site

City

Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07198

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07014

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

State/Province

Madrid, Communidad De

ZIP/Postal Code

28022

Country

Spain

Facility Name

Novartis Investigative Site

City

Mostoles

State/Province

Madrid, Communidad De

ZIP/Postal Code

28933

Country

Spain

Facility Name

Novartis Investigative Site

City

Valdemoro

State/Province

Madrid

ZIP/Postal Code

28342

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Linkoping

State/Province

Ostergotlands Lan

ZIP/Postal Code

587 58

Country

Sweden

Facility Name

Novartis Investigative Site

City

Goteborg

ZIP/Postal Code

413 46

Country

Sweden

Facility Name

Novartis Investigative Site

City

Gustavsberg

ZIP/Postal Code

134 44

Country

Sweden

Facility Name

Novartis Investigative Site

City

Helsingborg

ZIP/Postal Code

252 25

Country

Sweden

Facility Name

Novartis Investigative Site

City

Hollviken

ZIP/Postal Code

236 32

Country

Sweden

Facility Name

Novartis Investigative Site

City

Kungshamn

ZIP/Postal Code

456 31

Country

Sweden

Facility Name

Novartis Investigative Site

City

Limhamn

ZIP/Postal Code

216 43

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

222 22

Country

Sweden

Facility Name

Novartis Investigative Site

City

Råå

ZIP/Postal Code

252 70

Country

Sweden

Facility Name

Novartis Investigative Site

City

Umea

ZIP/Postal Code

907 40

Country

Sweden

Facility Name

Novartis Investigative Site

City

Vastra Frolunda

ZIP/Postal Code

421 44

Country

Sweden

Facility Name

Novartis Investigative Site

City

Aylesbury

State/Province

Bucks

ZIP/Postal Code

HP22 5LB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Fowey

State/Province

Cornwall

ZIP/Postal Code

PL23 1DT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liskeard

State/Province

Cornwall

ZIP/Postal Code

PL14 3XA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Penzance

State/Province

Cornwall

ZIP/Postal Code

TR18 AJH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Redruth

State/Province

Cornwall

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

St Austell

State/Province

Cornwall

ZIP/Postal Code

PL26 7RL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Torpoint

State/Province

Cornwall

ZIP/Postal Code

PL11 2TB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bath

State/Province

England

ZIP/Postal Code

BA2 3HT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Havant

State/Province

Hampshire

ZIP/Postal Code

PO9 1DQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Burbage

State/Province

Leicester

ZIP/Postal Code

LE10 2SE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Daventry

State/Province

Northamptonshire

ZIP/Postal Code

NN11 4DY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sneinton

State/Province

Nottingham

ZIP/Postal Code

NG3 7DQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Axbridge

State/Province

Somerset

ZIP/Postal Code

BS26 2BJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Frome

State/Province

Somerset

ZIP/Postal Code

BA11 2FH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Taunton

State/Province

Somerset

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

South Shields

State/Province

Tyne And Wear

ZIP/Postal Code

NE34 0PL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Barry

State/Province

Vale Of Glamorgan

ZIP/Postal Code

CF63 1BA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leamington Spa

State/Province

Warwickshire

ZIP/Postal Code

CV32 4RA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Crawley

State/Province

West Sussex

ZIP/Postal Code

RH10 7DX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Trowbridge

State/Province

Wiltshire

ZIP/Postal Code

BA14 8QA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Strensall

State/Province

Yorkshire

ZIP/Postal Code

YO32 5UA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bexhill-on-Sea

ZIP/Postal Code

TN40 1JJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

ZIP/Postal Code

BS10 6SP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

ZIP/Postal Code

BS48 1BZ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cardiff

ZIP/Postal Code

CF5 4AD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chadderton

ZIP/Postal Code

OL9 0LH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cheshire

ZIP/Postal Code

CW1 4QJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chesterfield

ZIP/Postal Code

S40 4AA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chippenham

ZIP/Postal Code

SN14 6GT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Coventry

ZIP/Postal Code

CV6 4DD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Hamilton

ZIP/Postal Code

ML3 8AA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Lancashire

ZIP/Postal Code

FY3 7EN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M8 9JT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Motherwell

ZIP/Postal Code

ML1 3JX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oldham

ZIP/Postal Code

OL9 8NH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Plymouth

ZIP/Postal Code

PL5 3JB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Shrewsbury

ZIP/Postal Code

SY38XQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

South Yorkshire

ZIP/Postal Code

DN9 1EP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Stockton on Tees

ZIP/Postal Code

TS19 8PE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Vale Of Glanmorgan

ZIP/Postal Code

CF63 4AR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Watford

ZIP/Postal Code

WD25 7NL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wiltshire

ZIP/Postal Code

SN15 2SB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wishaw

ZIP/Postal Code

ML2 0DP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29713156

Citation

Greulich T, Kostikas K, Gaga M, Aalamian-Mattheis M, Lossi NS, Patalano F, Nunez X, Pagano VA, Fogel R, Vogelmeier CF, Clemens A. Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1229-1237. doi: 10.2147/COPD.S159732. eCollection 2018.

Results Reference

derived

PubMed Identifier

28720132

Citation

Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, Ninane V, Lane S, Nunez X, Patalano F, Clemens A, Kostikas K; CRYSTAL study investigators. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.

Results Reference

derived

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Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

COPD

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial