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A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients (PARALLAX)

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

sacubitril/valsartan

Enalapril

Valsartan

Placebo to match sacubitril/valsartan

Placebo to match enalapril

Placebo to match valsartan

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring Cardiovascular Diseases, Heart Failure, Heart failure with Preserved Ejection Fraction, NT-proBNP, 6 MWT, KCCQ, SF-36, NYHA Class, LCZ696, Enalapril, Valsartan, Angiotensin-Converting Enzyme Inhibitors (ACEi), Angiotensin II Type 1 Receptor Blockers (ARB), Renin Angiotensin System Inhibitors (RASi)

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Left ventricular ejection fraction (LVEF) >40% by echo within 6 months prior to study entry or during the screening epoch
Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry
NYHA class II-IV
Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF
KCCQ clinical summary score < 75
Patients on ACEi or ARB therapy must have a history of HTN

Exclusion Criteria:

Any prior measurement of LVEF ≤ 40%, under stable conditions
Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be >40%
Current (within 30 days from Visit 1) acute decompensated HF requiring therapy.
Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696
History of hypersensitivity to LCZ696 or its components
Patients with a known history of angioedema
Walk distance primarily limited by non-cardiac comorbid conditions at study entry
Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL females, or body mass index (BMI) > 40 kg/m^2.
Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at study entry.
Patients with HbA1c > 7.5% not treated for diabetes
Patients with prior major organ transplant or intent to transplant (ie on transplant list)
eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening
Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at study entry
History or presence of any other disease with a life expectancy of < 3 years
Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sacubitril/valsartan (LCZ696)

Comparator

Arm Description

All patients who fulfill the inclusion/exclusion criteria will be stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi. Patients in the ACEi strata will receive LCZ696 or enalapril. Patients in the ARB strata will receive LCZ696 or valsartan. Patients in the no RASi strata will receive LCZ696 or matching placebo. Patients in the ACEi and ARB strata will take two pills twice daily for each dose: one tablet from the LCZ696 pack and one tablet from the comparator pack. Patients in the no RASi strata will take only one tablet twice daily (LCZ696 or matching placebo). In the LCZ696 arm, patients will receive active LCZ696 in titrated doses from level 1 up to level 3 (50 mg, 100 mg and 200 mg twice daily orally).

Patients randomized to the comparator arm will receive either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum). Patients in the ACE stratum randomized to comparator, will receive enalapril in titrated doses from level 1 up to level 3 (2.5 mg, 5 mg and 10 mg twice daily). Patients in the ARB stratum randomized to comparator will receive valsartan in titrated doses from level 1 up to level 3 (40 mg , 80 mg and 160 mg twice daily). Patients in the no RASi stratum randomized to comparator will receive LCZ696 matching placebo.

Outcomes

Primary Outcome Measures

Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12

To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT-proBNP from baseline at Week 12 in patients with HFpEF

Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24

Change from baseline in 6-minute walk distance (6MWD) will be reported at Week 24. The 6 MWT will be performed in accordance with the guidelines of the American Thoracic Society 2002.

Secondary Outcome Measures

Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24

The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.

Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24

Percentage of patients with KCCQ CSS deterioration ≥ 5-points will be reported at Week 24. The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.

Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24

Percentage of patients with KCCQ CSS improvement ≥ 5-points will be reported at Week 24. The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.

Change From Baseline in NYHA Functional Class at Week 24

NYHA classification is a subjective physician's assessment of patient's functional capacity and symptomatic status and can change frequently over time. Class I - No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF Class II - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF Class III - Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF Class IV - Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest The NYHA class change will be analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively.

Change From Baseline in The Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

The SF-36 PCS score reflects the measure of quality of life based on the 36 questions which evaluate the person's physical, emotional, and mental status, including general health. Specifically, the SF-36 PCS score focuses on assessing the person's physical status. The score ranges from 0 to 100 with a higher score indicating a better status of physical wellbeing (range = 0 "worst"-100 "best").

Full Information

NCT ID

NCT03066804

First Posted

February 23, 2017

Last Updated

October 7, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03066804

Brief Title

A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

Acronym

PARALLAX

Official Title

A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

August 22, 2017 (Actual)

Primary Completion Date

October 28, 2019 (Actual)

Study Completion Date

October 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Detailed Description

This study was a 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate sacubitril/valsartan compared to individualized medical therapy on NT proBNP, exercise capacity, symptoms and QoL in patients with heart failure and preserved left ventricular ejection (HFpEF) fraction (LVEF > 40%). Patients were initially stratified into one of three strata according to prior treatment for comorbidities: Angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or no prior renin angiotensin system inhibitors (RASi). Patients in each stratum were randomized in a 1:1 ratio and received either sacubitril/valsartan or comparator (i.e. enalapril for patients in ACEi strata, valsartan for patients in the ARB strata and placebo for patients in the No RASi strata). There was no designated proportion of patients planned in each stratum; the strata were populated based upon the patient's prior treatment regimen. The study consisted of a screening epoch of up to 2 weeks and a randomized treatment epoch of 24 weeks, which included a 1 to 4 week study drug up-titration epoch followed by a 20 to 23 week maintenance epoch. Uptitration to target doses was recommended to occur within the first four weeks of the study, and was performed by Investigator's discretion based on the patient's clinical status.

6. Conditions and Keywords

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

Heart Failure With Preserved Ejection Fraction

Keywords

Cardiovascular Diseases, Heart Failure, Heart failure with Preserved Ejection Fraction, NT-proBNP, 6 MWT, KCCQ, SF-36, NYHA Class, LCZ696, Enalapril, Valsartan, Angiotensin-Converting Enzyme Inhibitors (ACEi), Angiotensin II Type 1 Receptor Blockers (ARB), Renin Angiotensin System Inhibitors (RASi)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2572 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sacubitril/valsartan (LCZ696)

Arm Type

Experimental

Arm Description

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

sacubitril/valsartan

Intervention Description

Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

Intervention Type

Drug

Intervention Name(s)

Enalapril

Intervention Description

Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

Intervention Type

Drug

Intervention Name(s)

Valsartan

Intervention Description

Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

Intervention Type

Drug

Intervention Name(s)

Placebo to match sacubitril/valsartan

Intervention Description

Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

Intervention Type

Drug

Intervention Name(s)

Placebo to match enalapril

Intervention Description

Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

Intervention Type

Drug

Intervention Name(s)

Placebo to match valsartan

Intervention Description

Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally

Primary Outcome Measure Information:

Title

Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12

Description

To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT-proBNP from baseline at Week 12 in patients with HFpEF

Time Frame

Baseline, week 12

Title

Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24

Description

Change from baseline in 6-minute walk distance (6MWD) will be reported at Week 24. The 6 MWT will be performed in accordance with the guidelines of the American Thoracic Society 2002.

Time Frame

Baseline, week 24

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in NYHA Functional Class at Week 24

Description

Time Frame

Baseline, week 24

Title

Change From Baseline in The Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

Description

Time Frame

Baseline, Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Left ventricular ejection fraction (LVEF) >40% by echo within 6 months prior to study entry or during the screening epoch Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry NYHA class II-IV Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram. NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF KCCQ clinical summary score < 75 Patients on ACEi or ARB therapy must have a history of HTN Exclusion Criteria: Any prior measurement of LVEF ≤ 40%, under stable conditions Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be >40% Current (within 30 days from Visit 1) acute decompensated HF requiring therapy. Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696 History of hypersensitivity to LCZ696 or its components Patients with a known history of angioedema Walk distance primarily limited by non-cardiac comorbid conditions at study entry Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL females, or body mass index (BMI) > 40 kg/m^2. Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at study entry. Patients with HbA1c > 7.5% not treated for diabetes Patients with prior major organ transplant or intent to transplant (ie on transplant list) eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at study entry History or presence of any other disease with a life expectancy of < 3 years Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply.

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

Andalusia

State/Province

Alabama

ZIP/Postal Code

36420

Country

United States

Facility Name

Novartis Investigative Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Novartis Investigative Site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92704

Country

United States

Facility Name

Novartis Investigative Site

City

Sylmar

State/Province

California

ZIP/Postal Code

91342

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novartis Investigative Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Novartis Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Novartis Investigative Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33312

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Novartis Investigative Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Novartis Investigative Site

City

Thomasville

State/Province

Georgia

ZIP/Postal Code

31792

Country

United States

Facility Name

Novartis Investigative Site

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60004

Country

United States

Facility Name

Novartis Investigative Site

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

Novartis Investigative Site

City

Chalmette

State/Province

Louisiana

ZIP/Postal Code

70043

Country

United States

Facility Name

Novartis Investigative Site

City

Houma

State/Province

Louisiana

ZIP/Postal Code

70360

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Novartis Investigative Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68526

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14621

Country

United States

Facility Name

Novartis Investigative Site

City

Marion

State/Province

Ohio

ZIP/Postal Code

43302

Country

United States

Facility Name

Novartis Investigative Site

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330

Country

United States

Facility Name

Novartis Investigative Site

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19001

Country

United States

Facility Name

Novartis Investigative Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57104

Country

United States

Facility Name

Novartis Investigative Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38301

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Novartis Investigative Site

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

Novartis Investigative Site

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Novartis Investigative Site

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878GEG

Country

Argentina

Facility Name

Novartis Investigative Site

City

Posadas

State/Province

Misiones

ZIP/Postal Code

N3300AHX

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad de Salta

State/Province

Provincia De Salta

ZIP/Postal Code

A4406BPF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Tucuman

State/Province

San Miguel De Tucuman

ZIP/Postal Code

T4000ICL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000IFL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1430EGF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000AAW

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000EVQ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5004BAL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5006CBI

Country

Argentina

Facility Name

Novartis Investigative Site

City

Formosa

ZIP/Postal Code

P3600

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Luis

ZIP/Postal Code

D5702JRS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

3080

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S2200

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000FWO

Country

Argentina

Facility Name

Novartis Investigative Site

City

Braunau

ZIP/Postal Code

A5280

Country

Austria

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Hall in Tirol

ZIP/Postal Code

6060

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Heusden-Zolder

ZIP/Postal Code

3550

Country

Belgium

Facility Name

Novartis Investigative Site

City

Huy

ZIP/Postal Code

4500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Fortaleza

State/Province

ZIP/Postal Code

60430 370

Country

Brazil

Facility Name

Novartis Investigative Site

City

Goiania

State/Province

ZIP/Postal Code

74223-130

Country

Brazil

Facility Name

Novartis Investigative Site

City

Goiania

State/Province

ZIP/Postal Code

74605 050

Country

Brazil

Facility Name

Novartis Investigative Site

City

Belo Horizonte

State/Province

ZIP/Postal Code

30140 062

Country

Brazil

Facility Name

Novartis Investigative Site

City

Belo Horizonte

State/Province

ZIP/Postal Code

30150-221

Country

Brazil

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80230 130

Country

Brazil

Facility Name

Novartis Investigative Site

City

Canoas

State/Province

Rio Grande Do Sul

ZIP/Postal Code

92425 900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90880-480

Country

Brazil

Facility Name

Novartis Investigative Site

City

Blumenau

State/Province

ZIP/Postal Code

89010 500

Country

Brazil

Facility Name

Novartis Investigative Site

City

Campinas

State/Province

ZIP/Postal Code

13060 080

Country

Brazil

Facility Name

Novartis Investigative Site

City

Ribeirao Preto

State/Province

ZIP/Postal Code

14048-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Jose do Rio Preto

State/Province

ZIP/Postal Code

15015-750

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Jose do Rio Preto

State/Province

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Burgas

ZIP/Postal Code

8018

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Pazardzhik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Pernik

ZIP/Postal Code

2300

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1G 1A7

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

Novartis Investigative Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6K 3W7

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Georges Beauce

State/Province

Quebec

ZIP/Postal Code

G5Y 4T8

Country

Canada

Facility Name

Novartis Investigative Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050036

Country

Colombia

Facility Name

Novartis Investigative Site

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760001

Country

Colombia

Facility Name

Novartis Investigative Site

City

Barranquilla

ZIP/Postal Code

080020

Country

Colombia

Facility Name

Novartis Investigative Site

City

Barranquilla

Country

Colombia

Facility Name

Novartis Investigative Site

City

Monteria

Country

Colombia

Facility Name

Novartis Investigative Site

City

San Gil

ZIP/Postal Code

684031

Country

Colombia

Facility Name

Novartis Investigative Site

City

Brandys nad Labem

State/Province

Czech Republic

ZIP/Postal Code

250 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

60200

Country

Czechia

Facility Name

Novartis Investigative Site

City

Cesky Krumlov

State/Province

Czech Republic

ZIP/Postal Code

381 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Jablonec nad Nisou

State/Province

Czech Republic

ZIP/Postal Code

466 60

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kromeriz

State/Province

Czech Republic

ZIP/Postal Code

767 55

Country

Czechia

Facility Name

Novartis Investigative Site

City

Liberec

State/Province

Czech Republic

ZIP/Postal Code

46063

Country

Czechia

Facility Name

Novartis Investigative Site

City

Louny

State/Province

Czech Republic

Country

Czechia

Facility Name

Novartis Investigative Site

City

Pardubice

State/Province

Czech Republic

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

State/Province

Czech Republic

ZIP/Postal Code

30100

Country

Czechia

Facility Name

Novartis Investigative Site

City

Svitavy

State/Province

Czech Republic

ZIP/Postal Code

568 25

Country

Czechia

Facility Name

Novartis Investigative Site

City

Tabor

State/Province

Czech Republic

ZIP/Postal Code

39003

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

JIhlava

State/Province

CZE

ZIP/Postal Code

58633

Country

Czechia

Facility Name

Novartis Investigative Site

City

Policska

State/Province

CZE

ZIP/Postal Code

57201

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kolin

ZIP/Postal Code

280 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc Lazce

ZIP/Postal Code

77900

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prerov

ZIP/Postal Code

751 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Valasske Mezirici

ZIP/Postal Code

75742

Country

Czechia

Facility Name

Novartis Investigative Site

City

Copenhagen NV

ZIP/Postal Code

DK-2400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Novartis Investigative Site

City

Randers

ZIP/Postal Code

8930

Country

Denmark

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Besancon cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Novartis Investigative Site

City

Chambray les Tours

ZIP/Postal Code

37170

Country

France

Facility Name

Novartis Investigative Site

City

Corbeil Essonnes

ZIP/Postal Code

91100

Country

France

Facility Name

Novartis Investigative Site

City

Le Coudray

ZIP/Postal Code

28630

Country

France

Facility Name

Novartis Investigative Site

City

Le Kremlin Bicetre

ZIP/Postal Code

94275

Country

France

Facility Name

Novartis Investigative Site

City

Limoges cedex

ZIP/Postal Code

87042

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13008

Country

France

Facility Name

Novartis Investigative Site

City

Rennes Cedex 9

ZIP/Postal Code

35033

Country

France

Facility Name

Novartis Investigative Site

City

Tourcoing

ZIP/Postal Code

59200

Country

France

Facility Name

Novartis Investigative Site

City

Valenciennes

ZIP/Postal Code

59300

Country

France

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bavaria

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

State/Province

DEU

ZIP/Postal Code

45138

Country

Germany

Facility Name

Novartis Investigative Site

City

Detmold

State/Province

NRW

ZIP/Postal Code

32756

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01099

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Homburg

ZIP/Postal Code

61348

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Oeynhausen

ZIP/Postal Code

32545

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin Buch

ZIP/Postal Code

13125

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

10789

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

12683

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

D 10559

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33604

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum Wattenscheid

ZIP/Postal Code

44866

Country

Germany

Facility Name

Novartis Investigative Site

City

Brueel

ZIP/Postal Code

19412

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09130

Country

Germany

Facility Name

Novartis Investigative Site

City

Coburg

ZIP/Postal Code

96450

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44379

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

01277

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Elsterwerda

ZIP/Postal Code

04910

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

ZIP/Postal Code

99097

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45277

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60594

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

65929

Country

Germany

Facility Name

Novartis Investigative Site

City

Fuerth

ZIP/Postal Code

90766

Country

Germany

Facility Name

Novartis Investigative Site

City

Fulda

ZIP/Postal Code

36037

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle Saale

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

21075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hassloch

ZIP/Postal Code

67454

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln-Nippes

ZIP/Postal Code

50733

Country

Germany

Facility Name

Novartis Investigative Site

City

Koln

ZIP/Postal Code

D-51065

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67067

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67071

Country

Germany

Facility Name

Novartis Investigative Site

City

Lüneburg

ZIP/Postal Code

21339

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55116

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

68165

Country

Germany

Facility Name

Novartis Investigative Site

City

Muehldorf

ZIP/Postal Code

84453

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Munich

ZIP/Postal Code

80638

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuruppin

ZIP/Postal Code

16816

Country

Germany

Facility Name

Novartis Investigative Site

City

Nienburg

ZIP/Postal Code

31582

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuremberg

ZIP/Postal Code

90402

Country

Germany

Facility Name

Novartis Investigative Site

City

Papenburg

ZIP/Postal Code

26871

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14471

Country

Germany

Facility Name

Novartis Investigative Site

City

Riesa

ZIP/Postal Code

01589

Country

Germany

Facility Name

Novartis Investigative Site

City

Rodgau

ZIP/Postal Code

63110

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18107

Country

Germany

Facility Name

Novartis Investigative Site

City

Rotenburg an der Fulda

ZIP/Postal Code

36199

Country

Germany

Facility Name

Novartis Investigative Site

City

Ruesselsheim

ZIP/Postal Code

65428

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwaebisch Hall

ZIP/Postal Code

74523

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57072

Country

Germany

Facility Name

Novartis Investigative Site

City

Stadtlohn

ZIP/Postal Code

48703

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89077

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Wallerfing

ZIP/Postal Code

94574

Country

Germany

Facility Name

Novartis Investigative Site

City

Wedel

ZIP/Postal Code

22880

Country

Germany

Facility Name

Novartis Investigative Site

City

Wismar

ZIP/Postal Code

23966

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01001

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mosanmagyarovar

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 060

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110007

Country

India

Facility Name

Novartis Investigative Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 060

Country

India

Facility Name

Novartis Investigative Site

City

Vadodara

State/Province

Gujarat

ZIP/Postal Code

390022

Country

India

Facility Name

Novartis Investigative Site

City

Manipal

State/Province

Karnataka

ZIP/Postal Code

576104

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440009

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422005

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharastra

ZIP/Postal Code

422007

Country

India

Facility Name

Novartis Investigative Site

City

Bikaner

State/Province

Rajasthan

ZIP/Postal Code

334003

Country

India

Facility Name

Novartis Investigative Site

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226003

Country

India

Facility Name

Novartis Investigative Site

City

India

ZIP/Postal Code

560040

Country

India

Facility Name

Novartis Investigative Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Novartis Investigative Site

City

Be'er Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Novartis Investigative Site

City

Hadera

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

310 9601

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Novartis Investigative Site

City

Cortona

State/Province

ZIP/Postal Code

52044

Country

Italy

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Legnano

State/Province

ZIP/Postal Code

20025

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Sesto San Giovanni

State/Province

ZIP/Postal Code

20099

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Rovigo

State/Province

ZIP/Postal Code

45100

Country

Italy

Facility Name

Novartis Investigative Site

City

Sassari

State/Province

ZIP/Postal Code

07100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cona

Country

Italy

Facility Name

Novartis Investigative Site

City

San Vito al Tagliamento

Country

Italy

Facility Name

Novartis Investigative Site

City

Liepaja

State/Province

LVA

ZIP/Postal Code

3401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Daugavpils

ZIP/Postal Code

LV-5417

Country

Latvia

Facility Name

Novartis Investigative Site

City

Ogre

ZIP/Postal Code

5001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1012

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

47144

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44200

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44670

Country

Mexico

Facility Name

Novartis Investigative Site

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Novartis Investigative Site

City

San Luis Potosi

ZIP/Postal Code

78200

Country

Mexico

Facility Name

Novartis Investigative Site

City

Almelo

ZIP/Postal Code

7609 PP

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1091AC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Deventer

ZIP/Postal Code

7416 SE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Doetinchem

ZIP/Postal Code

7009 BL

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Gouda

ZIP/Postal Code

2803 HH

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hardenberg

ZIP/Postal Code

7770 AA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Stadskanaal

ZIP/Postal Code

9501 HE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Trujillo

State/Province

La Libertad

Country

Peru

Facility Name

Novartis Investigative Site

City

Cercado De Lima

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Jesus Maria

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Borja

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Miguel

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Callao

ZIP/Postal Code

CALLAO 2

Country

Peru

Facility Name

Novartis Investigative Site

City

Braga

ZIP/Postal Code

4710243

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1495 005

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1500 650

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1600190

Country

Portugal

Facility Name

Novartis Investigative Site

City

Penafiel

ZIP/Postal Code

4564-007

Country

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Bucuresti

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Timisoara

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Timisoara

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Craiova

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Craiova

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Pitesti

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Targu Mures

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Timisoara

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Ekaterinburg

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Gatchina

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Ivanovo

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Moscow

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Moscow

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Moscow

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Moscow

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Moscow

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Nizhnii Novgorod

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Perm

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Rostov on Don

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Belgrade

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Presov

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Madrid

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Valencia

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10400

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Thailand

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Thailand

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Thailand

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Antalya

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Aydin

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Istanbul

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Turkey

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Istanbul

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Turkey

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Izmir

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35040

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Turkey

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Izmir

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35340

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Turkey

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Kocaeli

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Mersin

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Sivas

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58140

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Turkey

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Talas / Kayseri

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38039

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Turkey

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High Wycombe

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Buckinghamshire

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HP11 2TT

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United Kingdom

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Stockton on Tees

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Cleveland

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United Kingdom

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Chesterfield

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Derbyshire

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United Kingdom

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Craigavon

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Northern Ireland

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United Kingdom

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Wansford

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United Kingdom

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Addlestone

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Surrey

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KT15 2BH

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United Kingdom

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Sunderland

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Tyne And Wear

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SR4 7TP

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United Kingdom

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Leeds

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LS1 3EX

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United Kingdom

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Novartis Investigative Site

City

York

ZIP/Postal Code

YO31 8HE

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United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

34783839

Citation

Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

Results Reference

derived

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=740

Description

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Learn more about this trial

A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

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A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients (PARALLAX)

Heart Failure With Preserved Ejection Fraction

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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