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Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Primary Purpose

Asthma

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

QAW039 150 mg

QAW039 450 mg

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, QAW039, allergic asthma, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing

Eligibility Criteria

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

Inclusion Criteria:

Patients completing a prior Phase 3 study of QAW039:

Informed consent and assent (if applicable).
Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
Patient is able to safely continue into the study as judged by the investigator.

Patients who have not previously participated in a study of QAW039:

Written informed consent.
A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.
Evidence of airway reversibility or airway hyper- reactivity.
FEV1 of ≤85% of the predicted normal value.
An ACQ score ≥1.5 prior to entering the study.

Exclusion Criteria:

Patients completing a prior phase 3 study of QAW039:

Pregnant or nursing (lactating) women.
Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
Inability to comply with all study requirements.
Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.

Patients who have not previously participated in a study of QAW039:

Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
Subjects who have participated in another trial of QAW039 (i.e.-the patient was randomized in another study).
A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
History of malignancy with the exception of local basal cell carcinoma of the skin
Pregnant or nursing (lactating) women.
Serious co-morbidities.
Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

QAW039 150mg

QAW039 450 mg

Placebo

Arm Description

QAW039 Dose 1 once daily

QAW039 Dose 2 once daily

Placebo once daily

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model

Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model

Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported.

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model

Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.

Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model

Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported.

Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model

Secondary Outcome Measures

Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model

The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)

Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model

Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52

The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156

The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52

Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE). Rate of exacerbations per person year = total number of exacerbations / total number of treatment years

Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156

Full Information

NCT ID

NCT03052517

First Posted

January 23, 2017

Last Updated

September 14, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03052517

Brief Title

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Official Title

A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Terminated

Why Stopped

Company Decision

Study Start Date

March 21, 2017 (Actual)

Primary Completion Date

February 19, 2020 (Actual)

Study Completion Date

March 16, 2020 (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

5. Study Description

Brief Summary

This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

Detailed Description

The study comprised 2-treatment period. Treatment Period 1 was a 52-week, double-blind treatment period in which QAW039 450 mg or 150 mg or placebo was added to standard-of-care asthma therapy according to GINA guidelines. Treatment Period 2 was an optional 104-week, single-blind treatment period in which patients received QAW039 450 mg or 150 mg or placebo added to standard-of-care asthma therapy according to GINA guidelines.

6. Conditions and Keywords

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

Asthma

Keywords

Asthma, QAW039, allergic asthma, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2538 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QAW039 150mg

Arm Type

Experimental

Arm Description

QAW039 Dose 1 once daily

Arm Title

QAW039 450 mg

Arm Type

Experimental

Arm Description

QAW039 Dose 2 once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo once daily

Intervention Type

Drug

Intervention Name(s)

QAW039 150 mg

Intervention Description

One tablet of QAW039 150 mg once daily

Intervention Type

Drug

Intervention Name(s)

QAW039 450 mg

Intervention Description

One tablet of QAW039 450 mg once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One tablet of Placebo once daily

Primary Outcome Measure Information:

Title

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model

Description

Time Frame

52 weeks

Title

Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model

Description

Time Frame

156 weeks

Title

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model

Description

Time Frame

52 weeks

Title

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model

Description

Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.

Time Frame

156 weeks

Title

Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model

Description

Time Frame

52 weeks

Title

Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model

Description

Time Frame

156 weeks

Secondary Outcome Measure Information:

Title

Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model

Description

Time Frame

52 weeks

Title

Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model

Description

Time Frame

156 weeks

Title

Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52

Description

The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

Time Frame

52 weeks

Title

Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156

Description

The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.

Time Frame

156 weeks

Title

Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52

Description

Time Frame

52 weeks

Title

Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156

Description

Time Frame

156 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients completing a prior Phase 3 study of QAW039: Informed consent and assent (if applicable). Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039. Patient is able to safely continue into the study as judged by the investigator. Patients who have not previously participated in a study of QAW039: Written informed consent. A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication. Evidence of airway reversibility or airway hyper- reactivity. FEV1 of ≤85% of the predicted normal value. An ACQ score ≥1.5 prior to entering the study. Exclusion Criteria: Patients completing a prior phase 3 study of QAW039: Pregnant or nursing (lactating) women. Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in. Inability to comply with all study requirements. Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in. Patients who have not previously participated in a study of QAW039: Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer. Subjects who have participated in another trial of QAW039 (i.e.-the patient was randomized in another study). A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female). History of malignancy with the exception of local basal cell carcinoma of the skin Pregnant or nursing (lactating) women. Serious co-morbidities. Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Novartis Investigative Site

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Novartis Investigative Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Novartis Investigative Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92117

Country

United States

Facility Name

Novartis Investigative Site

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Novartis Investigative Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novartis Investigative Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Novartis Investigative Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Novartis Investigative Site

City

Lafayette

State/Province

Colorado

ZIP/Postal Code

80026

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Novartis Investigative Site

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Novartis Investigative Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Novartis Investigative Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Novartis Investigative Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

Novartis Investigative Site

City

Zachary

State/Province

Louisiana

ZIP/Postal Code

70791

Country

United States

Facility Name

Novartis Investigative Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

Novartis Investigative Site

City

Waldorf

State/Province

Maryland

ZIP/Postal Code

20602

Country

United States

Facility Name

Novartis Investigative Site

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

Novartis Investigative Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59804

Country

United States

Facility Name

Novartis Investigative Site

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68123

Country

United States

Facility Name

Novartis Investigative Site

City

La Vista

State/Province

Nebraska

ZIP/Postal Code

68128

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Novartis Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10459

Country

United States

Facility Name

Novartis Investigative Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Novartis Investigative Site

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Novartis Investigative Site

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Novartis Investigative Site

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15221

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Novartis Investigative Site

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02941

Country

United States

Facility Name

Novartis Investigative Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76244

Country

United States

Facility Name

Novartis Investigative Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Novartis Investigative Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23225

Country

United States

Facility Name

Novartis Investigative Site

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

Facility Name

Novartis Investigative Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Novartis Investigative Site

City

Berazategui

State/Province

Buenos Aires

ZIP/Postal Code

1888

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Novartis Investigative Site

City

Lanus

State/Province

Buenos Aires

ZIP/Postal Code

B8000XAV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ranelagh, Partido De Berazate

State/Province

Buenos Aires

ZIP/Postal Code

1884

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Rosa

State/Province

La Pampa

ZIP/Postal Code

6300

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

State/Province

Rosario

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000AII

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000BRH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000JKR

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

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

C1012AAR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1425FVH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

M5500CBA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Salta

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000FIL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Novartis Investigative Site

City

Footscray

State/Province

Victoria

ZIP/Postal Code

3011

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Novartis Investigative Site

City

Feldkirch

ZIP/Postal Code

6800

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

A-1130

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A 1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

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

Herentals

ZIP/Postal Code

2200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Goiania

State/Province

ZIP/Postal Code

74110-030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

Porto Alegre RS

ZIP/Postal Code

90610 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

21941-590

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Novartis Investigative Site

City

Blumenau

State/Province

Santa Catarina

ZIP/Postal Code

89030101

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Bernardo do Campo

State/Province

ZIP/Postal Code

09715 090

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05437 010

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sorocaba

State/Province

Country

Brazil

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6H 3M2

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1L5

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1V 4W2

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

Country

Canada

Facility Name

Novartis Investigative Site

City

Guang Zhou

State/Province

Guang Dong Province

ZIP/Postal Code

510120

Country

China

Facility Name

Novartis Investigative Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210006

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Facility Name

Novartis Investigative Site

City

Chang Chun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110000

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110003

Country

China

Facility Name

Novartis Investigative Site

City

Xian

State/Province

Shanxi

ZIP/Postal Code

710061

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Novartis Investigative Site

City

Ibague

State/Province

Tolima

ZIP/Postal Code

730006

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bucaramanga

Country

Colombia

Facility Name

Novartis Investigative Site

City

Jindrichuv Hradec

State/Province

Czech Republic

ZIP/Postal Code

377 01

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

Teplice

State/Province

CZE

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

615 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Karlovy Vary

ZIP/Postal Code

360 17

Country

Czechia

Facility Name

Novartis Investigative Site

City

Mlada Boleslav

ZIP/Postal Code

293 50

Country

Czechia

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

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

State/Province

Herault

ZIP/Postal Code

34059

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Novartis Investigative Site

City

Le Kremlin Bicetre

ZIP/Postal Code

94275

Country

France

Facility Name

Novartis Investigative Site

City

Lyon Cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13015

Country

France

Facility Name

Novartis Investigative Site

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Paris cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Novartis Investigative Site

City

Cottbus

State/Province

Sachsen

ZIP/Postal Code

03050

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

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

10969

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

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

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

04357

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 25

Country

Greece

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

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 21

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

175 62

Country

Greece

Facility Name

Novartis Investigative Site

City

Gautemala City

State/Province

Gautemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

State/Province

GTM

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

State/Province

GTM

ZIP/Postal Code

01011

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

Budaors

State/Province

HUN

ZIP/Postal Code

2040

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

State/Province

HUN

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hajdunanas

State/Province

HUN

ZIP/Postal Code

4080

Country

Hungary

Facility Name

Novartis Investigative Site

City

Puspokladany

State/Province

HUN

ZIP/Postal Code

4150

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szazhalombatta

State/Province

HUN

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

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

Pecs

ZIP/Postal Code

7635

Country

Hungary

Facility Name

Novartis Investigative Site

City

Siofok

ZIP/Postal Code

8600

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

Facility Name

Novartis Investigative Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

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

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440015

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411014

Country

India

Facility Name

Novartis Investigative Site

City

Bikaner

State/Province

Rajasthan

ZIP/Postal Code

334 001

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302039

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641 045

Country

India

Facility Name

Novartis Investigative Site

City

DehraDun

State/Province

Uttarakhand

ZIP/Postal Code

248001

Country

India

Facility Name

Novartis Investigative Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

310 9601

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3436212

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466 8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsuyama-city

State/Province

Ehime

ZIP/Postal Code

790-0024

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsuyama-city

State/Province

Ehime

ZIP/Postal Code

790-8524

Country

Japan

Facility Name

Novartis Investigative Site

City

Chikushino-city

State/Province

Fukuoka

ZIP/Postal Code

818-8502

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka city

State/Province

Fukuoka

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

Novartis Investigative Site

City

Iizuka-city

State/Province

Fukuoka

ZIP/Postal Code

820-8505

Country

Japan

Facility Name

Novartis Investigative Site

City

Kasuga-city

State/Province

Fukuoka

ZIP/Postal Code

816-0813

Country

Japan

Facility Name

Novartis Investigative Site

City

Koga city

State/Province

Fukuoka

ZIP/Postal Code

811 3195

Country

Japan

Facility Name

Novartis Investigative Site

City

Yanagawa-city

State/Province

Fukuoka

ZIP/Postal Code

832-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Mizunami-city

State/Province

Gifu

ZIP/Postal Code

509 6134

Country

Japan

Facility Name

Novartis Investigative Site

City

Hiroshima-city

State/Province

Hiroshima

ZIP/Postal Code

734-8530

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

062-0931

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

064-0804

Country

Japan

Facility Name

Novartis Investigative Site

City

Himeji-city

State/Province

Hyogo

ZIP/Postal Code

672-8064

Country

Japan

Facility Name

Novartis Investigative Site

City

Naka-gun

State/Province

Ibaraki

ZIP/Postal Code

319-1113

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakaide

State/Province

Kagawa

ZIP/Postal Code

762-8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Takamatsu-city

State/Province

Kagawa

ZIP/Postal Code

761-8073

Country

Japan

Facility Name

Novartis Investigative Site

City

Kagoshima city

State/Province

Kagoshima

ZIP/Postal Code

890 8520

Country

Japan

Facility Name

Novartis Investigative Site

City

Sagamihara-city

State/Province

Kanagawa

ZIP/Postal Code

228-8522

Country

Japan

Facility Name

Novartis Investigative Site

City

Sagamihara-city

State/Province

Kanagawa

ZIP/Postal Code

229-1103

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama city

State/Province

Kanagawa

ZIP/Postal Code

232 0024

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

223-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

234-0054

Country

Japan

Facility Name

Novartis Investigative Site

City

Koshi-city

State/Province

Kumamoto

ZIP/Postal Code

861-1196

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsusaka-city

State/Province

Mie

ZIP/Postal Code

515-8544

Country

Japan

Facility Name

Novartis Investigative Site

City

Tsu-city

State/Province

Mie

ZIP/Postal Code

514-0125

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai-city

State/Province

Miyagi

ZIP/Postal Code

980-0871

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai-city

State/Province

Miyagi

ZIP/Postal Code

984-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Kashihara city

State/Province

Nara

ZIP/Postal Code

634 8522

Country

Japan

Facility Name

Novartis Investigative Site

City

Habikino city

State/Province

Osaka

ZIP/Postal Code

583 8588

Country

Japan

Facility Name

Novartis Investigative Site

City

Kishiwada-city

State/Province

Osaka

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

State/Province

Shibuya Ku

ZIP/Postal Code

150 0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu-city

State/Province

Shizuoka

ZIP/Postal Code

431-3192

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo ku

State/Province

Tokyo

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo ku

State/Province

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Kiyose-city

State/Province

Tokyo

ZIP/Postal Code

204-8585

Country

Japan

Facility Name

Novartis Investigative Site

City

Ota-ku

State/Province

Tokyo

ZIP/Postal Code

145 0063

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-Ku

State/Province

Tokyo

ZIP/Postal Code

157-0072

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

157006

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku ku

State/Province

Tokyo

ZIP/Postal Code

162 8655

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

169-0073

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima ku

State/Province

Tokyo

ZIP/Postal Code

170 0003

Country

Japan

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

El Chouf

State/Province

LBN

ZIP/Postal Code

1503201002

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Ashrafieh

ZIP/Postal Code

166830

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

ZIP/Postal Code

166378

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

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-45130

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

LT-50128

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92231

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-04129

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kota Bharu

State/Province

Kelantan

ZIP/Postal Code

15586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuantan

State/Province

Pahang

ZIP/Postal Code

25100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Taiping

State/Province

Perak

ZIP/Postal Code

34000

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Guadalajara Jalisco

State/Province

Jalisco

ZIP/Postal Code

44220

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Novartis Investigative Site

City

Rio De Janeiro

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Novartis Investigative Site

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Cercado De Lima

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 Martin de Porres

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Cusco

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Piura

ZIP/Postal Code

2000

Country

Peru

Facility Name

Novartis Investigative Site

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

State/Province

Manila

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bulacan

ZIP/Postal Code

3020

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-010

Country

Poland

Facility Name

Novartis Investigative Site

City

Kielce

ZIP/Postal Code

25-371

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-214

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-823

Country

Poland

Facility Name

Novartis Investigative Site

City

Strzelce Opolskie

ZIP/Postal Code

47 100

Country

Poland

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 3

ZIP/Postal Code

030303

Country

Romania

Facility Name

Novartis Investigative Site

City

Constanta

State/Province

ROM

ZIP/Postal Code

900412

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300310

Country

Romania

Facility Name

Novartis Investigative Site

City

Bragadiru

ZIP/Postal Code

077025

Country

Romania

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500051

Country

Romania

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500086

Country

Romania

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500366

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400139

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Novartis Investigative Site

City

Deva

ZIP/Postal Code

330162

Country

Romania

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Izhevsk

ZIP/Postal Code

426061

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125315

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhnii Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Penza

ZIP/Postal Code

440067

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Perm

ZIP/Postal Code

614068

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

191186

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sestroretsk

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Stavropol

ZIP/Postal Code

355000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150054

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Jeddah

ZIP/Postal Code

21423

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11070

Country

Serbia

Facility Name

Novartis Investigative Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Sremska Kamenica

ZIP/Postal Code

21204

Country

Serbia

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

Facility Name

Novartis Investigative Site

City

Bardejov

State/Province

Slovak Republic

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bojnice

State/Province

Slovak Republic

ZIP/Postal Code

972 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kezmarok

ZIP/Postal Code

060 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Komarno

ZIP/Postal Code

945 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Levice

ZIP/Postal Code

934 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Levice

ZIP/Postal Code

93401

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Spisska Nova Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

01207

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29009

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Marbella

State/Province

Andalucia

ZIP/Postal Code

29603

Country

Spain

Facility Name

Novartis Investigative Site

City

Jerez

State/Province

Cadiz

ZIP/Postal Code

11407

Country

Spain

Facility Name

Novartis Investigative Site

City

Laredo

State/Province

Cantabria

ZIP/Postal Code

39770

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Lugo

State/Province

Galicia

ZIP/Postal Code

27003

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07010

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Vic

ZIP/Postal Code

08500

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08006

Country

Spain

Facility Name

Novartis Investigative Site

City

Girona

ZIP/Postal Code

17005

Country

Spain

Facility Name

Novartis Investigative Site

City

Guadalajara

ZIP/Postal Code

19002

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

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

Liestal

ZIP/Postal Code

4410

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33343

Country

Turkey

Facility Name

Novartis Investigative Site

City

Yenisehir/Izmir

ZIP/Postal Code

35110

Country

Turkey

Facility Name

Novartis Investigative Site

City

Cambridge

State/Province

Cambrigdeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chertsey

State/Province

Surrey

ZIP/Postal Code

KT16 0PZ

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

East Yorkshire

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE3 9QP

Country

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

34895218

Citation

Maspero J, Agache IO, Kamei T, Yoshida M, Boone B, Felser JM, Kawakami F, Knorr B, Lawrence D, Lehmann T, Wang W, Pedinoff AJ. Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial. Respir Res. 2021 Dec 11;22(1):311. doi: 10.1186/s12931-021-01904-8.

Results Reference

derived

Learn more about this trial

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

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Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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