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Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI (PARADISE-MI)

Primary Purpose

Acute Myocardial Infarction

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LCZ696 (sacubitril/valsartan)

Ramipril

Placebo of LCZ696

Placebo of ramipril

Valsartan

Placebo of valsartan

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Spontaneous AMI, HF hospitalization, outpatient HF, LV systolic dysfunction, pulmonary congestion, STEMI, NSTEMI, randomized clinical trial, LCZ696, ramipril

Eligibility Criteria

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

Inclusion Criteria:

Male or female patients ≥ 18 years of age.
Diagnosis of spontaneous AMI based on the universal MI definition* with randomization to occur between 12 hours and 7 days after index event presentation. (*patients with spontaneous MI event determined to be secondary to another medical condition such as anemia, hypotension, or arrhythmia OR thought to be caused by coronary vasospasm with document normal coronary arteries are not eligible; patients with clinical presentation thought to be related to Takotsubo cardiomyopathy are also not eligible)
Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event defined as:
- LVEF ≤40% after index MI presentation and prior to randomization and/or
- Pulmonary congestion requiring intravenous treatment with diuretics, vasodilators, vasopressors and/or inotropes, during the index hospitalization
At least one of the following 8 risk factors:
- Age ≥ 70 years
- eGFR <60 mL/min/1.73 m^2 based on MDRD formula at screening visit
- Type I or II diabetes mellitus
- Documented history of prior MI
- Atrial fibrillation as noted by ECG, associated with index MI
- LVEF <30% associated with index MI
- Worst Killip class III or IV associated with index MI requiring intravenous treatment
- STEMI without reperfusion therapy within the first 24 hours after presentation
Hemodynamically stable defined as:
- SBP ≥ 100 mmHg at randomization for patients who received ACEi/ARB during the last 24 hours prior to randomization
- SBP ≥ 110 mmHg at randomization for patients who did not receive ACEi/ARB during the last 24 hours prior to randomization
- No IV treatment with diuretics, vasodilators, vasopressors and/or inotropes during the 24 hours prior to randomization

Key Exclusion Criteria:

Known history of chronic HF prior to randomization
Cardiogenic shock within the last 24 hours prior to randomization
Persistent clinical HF at the time of randomization
Coronary artery bypass graft (CABG) performed or planned for index MI
Clinically significant right ventricular MI as index MI
Symptomatic hypotension at screening or randomization
Patients with a known history of angioedema
Stroke or transient ischemic attack within one month prior to randomization
Known or suspected bilateral renal artery stenosis
Clinically significant obstructive cardiomyopathy
Open-heart surgery performed within one month prior to randomization or planned cardiac surgery w/in the 3 months prior to randomization
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 randomization
Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
Previous use of LCZ696
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 3 years with a life expectancy of less than 1year.
History of hypersensitivity to the study drugs or drugs of similar chemical classes or known intolerance or contraindications to study drugs or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LCZ696 (sacubitril/valsartan)

Ramipril

Arm Description

Following randomization, patients will receive LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily). Patients will be required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from ramipril matching placebo pack) twice a day for the duration of the study. Patients randomized to LCZ who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization will receive a valsartan bridge for one day. These patients will receive two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.

Following randomization, patients will receive the Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily). Patients will be required to take a total of two pills, (one capsule from the ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study. Patients randomized to ramipril who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization will immediately start on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients will receive two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.

Outcomes

Primary Outcome Measures

Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint

A confirmed composite endpoint includes cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient heart failure

Secondary Outcome Measures

Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization

A confirmed composite endpoint for this outcome measure includes cardiovascular death or heart failure hospitalization.

Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF

A confirmed composite endpoint includes first occurrence of heart failure hospitalization or outpatient heart failure

Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke

A confirmed composite endpoint for this outcome measure includes cardiovascular death, non-fatal spontaneous myocardial infarction or non-fatal stroke

Total Number of Confirmed Composite Endpoints

A confirmed composite endpoint includes cardiovascular death, heart failure hospitalization, non-fatal spontaneous MI hospitalization, and non-fatal stroke hospitalization

All-cause Mortality for Full Analysis Set (FAS)

All-cause mortality defined as deaths related to Cardiovascular (CV) and non-CV events for patients in the Full Analysis Set up to a cut-off date of 31-Dec-2020.

Full Information

NCT ID

NCT02924727

First Posted

October 4, 2016

Last Updated

June 16, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02924727

Brief Title

Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

Acronym

PARADISE-MI

Official Title

A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an Acute Myocardial Infarction (AMI)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

December 9, 2016 (Actual)

Primary Completion Date

February 26, 2021 (Actual)

Study Completion Date

February 26, 2021 (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 evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF.

6. Conditions and Keywords

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

Acute Myocardial Infarction

Keywords

Spontaneous AMI, HF hospitalization, outpatient HF, LV systolic dysfunction, pulmonary congestion, STEMI, NSTEMI, randomized clinical trial, LCZ696, ramipril

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5669 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCZ696 (sacubitril/valsartan)

Arm Type

Experimental

Arm Description

Arm Title

Ramipril

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

LCZ696 (sacubitril/valsartan)

Intervention Description

LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively

Intervention Type

Drug

Intervention Name(s)

Ramipril

Intervention Description

Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules

Intervention Type

Drug

Intervention Name(s)

Placebo of LCZ696

Intervention Description

Matching placebo of LCZ696 tablets

Intervention Type

Drug

Intervention Name(s)

Placebo of ramipril

Intervention Description

Matching placebo of ramipril capsule

Intervention Type

Drug

Intervention Name(s)

Valsartan

Intervention Description

Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day to patients who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization

Intervention Type

Drug

Intervention Name(s)

Placebo of valsartan

Intervention Description

matching placebo of valsartan for one day to patients who will be randomized to received ramipril

Primary Outcome Measure Information:

Title

Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint

Description

A confirmed composite endpoint includes cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient heart failure

Time Frame

From randomization to first occurrence (up to approximately 43 months)

Secondary Outcome Measure Information:

Title

Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization

Description

A confirmed composite endpoint for this outcome measure includes cardiovascular death or heart failure hospitalization.

Time Frame

Time from randomization to first occurrence (up to approximately 43 months)

Title

Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF

Description

A confirmed composite endpoint includes first occurrence of heart failure hospitalization or outpatient heart failure

Time Frame

Time from randomization to first occurrence (approximately up to 43 months)

Title

Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke

Description

A confirmed composite endpoint for this outcome measure includes cardiovascular death, non-fatal spontaneous myocardial infarction or non-fatal stroke

Time Frame

Time from randomization to first occurrence (approximately up to 43 months)

Title

Total Number of Confirmed Composite Endpoints

Description

A confirmed composite endpoint includes cardiovascular death, heart failure hospitalization, non-fatal spontaneous MI hospitalization, and non-fatal stroke hospitalization

Time Frame

Time from randomization to end of study (approximately up to 43 months)

Title

All-cause Mortality for Full Analysis Set (FAS)

Description

All-cause mortality defined as deaths related to Cardiovascular (CV) and non-CV events for patients in the Full Analysis Set up to a cut-off date of 31-Dec-2020.

Time Frame

Time from randomization to death (approximately up to 43 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients ≥ 18 years of age. Diagnosis of spontaneous AMI based on the universal MI definition* with randomization to occur between 12 hours and 7 days after index event presentation. (*patients with spontaneous MI event determined to be secondary to another medical condition such as anemia, hypotension, or arrhythmia OR thought to be caused by coronary vasospasm with document normal coronary arteries are not eligible; patients with clinical presentation thought to be related to Takotsubo cardiomyopathy are also not eligible) Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event defined as: LVEF ≤40% after index MI presentation and prior to randomization and/or Pulmonary congestion requiring intravenous treatment with diuretics, vasodilators, vasopressors and/or inotropes, during the index hospitalization At least one of the following 8 risk factors: Age ≥ 70 years eGFR <60 mL/min/1.73 m^2 based on MDRD formula at screening visit Type I or II diabetes mellitus Documented history of prior MI Atrial fibrillation as noted by ECG, associated with index MI LVEF <30% associated with index MI Worst Killip class III or IV associated with index MI requiring intravenous treatment STEMI without reperfusion therapy within the first 24 hours after presentation Hemodynamically stable defined as: SBP ≥ 100 mmHg at randomization for patients who received ACEi/ARB during the last 24 hours prior to randomization SBP ≥ 110 mmHg at randomization for patients who did not receive ACEi/ARB during the last 24 hours prior to randomization No IV treatment with diuretics, vasodilators, vasopressors and/or inotropes during the 24 hours prior to randomization Key Exclusion Criteria: Known history of chronic HF prior to randomization Cardiogenic shock within the last 24 hours prior to randomization Persistent clinical HF at the time of randomization Coronary artery bypass graft (CABG) performed or planned for index MI Clinically significant right ventricular MI as index MI Symptomatic hypotension at screening or randomization Patients with a known history of angioedema Stroke or transient ischemic attack within one month prior to randomization Known or suspected bilateral renal artery stenosis Clinically significant obstructive cardiomyopathy Open-heart surgery performed within one month prior to randomization or planned cardiac surgery w/in the 3 months prior to randomization 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 randomization Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices Previous use of LCZ696 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 3 years with a life expectancy of less than 1year. History of hypersensitivity to the study drugs or drugs of similar chemical classes or known intolerance or contraindications to study drugs or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35243

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United States

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Novartis Investigative Site

City

Birmingham

State/Province

Alabama

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35294-2041

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United States

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Huntsville

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Alabama

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35801

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United States

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Gilbert

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Arizona

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85297

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Bakersfield

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California

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93301

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Carmichael

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95608

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Los Alamitos

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90720

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Northridge

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91325

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Orange

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San Francisco

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Sylmar

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Hollywood

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Jacksonville Beach

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Ocala

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Petoskey

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Lincoln

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Chapel Hill

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Charlotte

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Charleston

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Columbia

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South Carolina

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29203

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Greenville

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South Carolina

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29607

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Rapid City

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South Dakota

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57701

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United States

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Knoxville

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Tennessee

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37917

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United States

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Nashville

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Tennessee

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37212

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United States

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Dallas

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Texas

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75226

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United States

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Novartis Investigative Site

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Houston

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Texas

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77030

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Novartis Investigative Site

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Webster

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Texas

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77598

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Danville

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Virginia

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24541

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United States

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Falls Church

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Virginia

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22042

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Lynchburg

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Virginia

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24501

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United States

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Manassas

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Virginia

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20109

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United States

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Bellevue

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Washington

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98004

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United States

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Novartis Investigative Site

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Caba

State/Province

Buenos Aires

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C1280AEB

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Argentina

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Novartis Investigative Site

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La Plata

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Buenos Aires

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Argentina

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Novartis Investigative Site

City

Buenos Aires

State/Province

Caba

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Argentina

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Novartis Investigative Site

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Ciudad de Salta

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Provincia De Salta

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A4406BPF

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Argentina

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Novartis Investigative Site

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Tucuman

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San Miguel De Tucuman

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Argentina

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Novartis Investigative Site

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Rosario

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Santa Fe

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Argentina

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Novartis Investigative Site

City

Rosario

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Santa Fe

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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

B1602ABQ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

B1846BMF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1405CNF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1428DCO

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

X5000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5003DCP

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

Corrientes

ZIP/Postal Code

W3400

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

S3000FUJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Chemside

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

Novartis Investigative Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Novartis Investigative Site

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5041

Country

Australia

Facility Name

Novartis Investigative Site

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Novartis Investigative Site

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

Novartis Investigative Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Novartis Investigative Site

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Braunau

ZIP/Postal Code

A5280

Country

Austria

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

St Poelten

ZIP/Postal Code

3100

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1210

Country

Austria

Facility Name

Novartis Investigative Site

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Novartis Investigative Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Turnhout

ZIP/Postal Code

2300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Yvoir

ZIP/Postal Code

5530

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

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

Uberlandia

State/Province

Minas Gerais

ZIP/Postal Code

38411 186

Country

Brazil

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80730 150

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90620 001

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

91350 200

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

Sao Jose do Rio Preto

State/Province

ZIP/Postal Code

15090 000

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

Campina Grande do Sul

ZIP/Postal Code

83430 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Jose

ZIP/Postal Code

8001

Country

Brazil

Facility Name

Novartis Investigative Site

City

Burgas

State/Province

BGR

ZIP/Postal Code

8018

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

State/Province

BGR

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Burgas

ZIP/Postal Code

8127

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Gabrovo

ZIP/Postal Code

5300

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Kardzhali

ZIP/Postal Code

6600

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

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1202

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

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2E1

Country

Canada

Facility Name

Novartis Investigative Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R4R2

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4W7

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

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

Sainte Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novartis Investigative Site

City

Terrebonne

State/Province

Quebec

ZIP/Postal Code

J6V 2H2

Country

Canada

Facility Name

Novartis Investigative Site

City

Trois Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 3R9

Country

Canada

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Facility Name

Novartis Investigative Site

City

Xicheng

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Novartis Investigative Site

City

Lanzhou

State/Province

Gansu

ZIP/Postal Code

730030

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

51000

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

Novartis Investigative Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Facility Name

Novartis Investigative Site

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150000

Country

China

Facility Name

Novartis Investigative Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430060

Country

China

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

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

Yanji

State/Province

Jilin

ZIP/Postal Code

133001

Country

China

Facility Name

Novartis Investigative Site

City

Shengyang

State/Province

Liaoning

ZIP/Postal Code

110016

Country

China

Facility Name

Novartis Investigative Site

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250013

Country

China

Facility Name

Novartis Investigative Site

City

Jinshan

State/Province

Shanghai

ZIP/Postal Code

201508

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200120

Country

China

Facility Name

Novartis Investigative Site

City

Xian

State/Province

Shanxi

ZIP/Postal Code

710061

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300121

Country

China

Facility Name

Novartis Investigative Site

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100029

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Novartis Investigative Site

City

Wuhan

ZIP/Postal Code

430022

Country

China

Facility Name

Novartis Investigative Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050001

Country

Colombia

Facility Name

Novartis Investigative Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

6CM8+47

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bucaramanga

State/Province

Santander

ZIP/Postal Code

65265

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

Bogota

ZIP/Postal Code

110010

Country

Colombia

Facility Name

Novartis Investigative Site

City

Zagreb

State/Province

HRV

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Cakovec

ZIP/Postal Code

40000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Kladno

State/Province

Czech Republic

ZIP/Postal Code

272 00

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

Zlin

State/Province

Czech Republic

ZIP/Postal Code

762 75

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno Bohunice

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen-Bory

ZIP/Postal Code

305 99

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 4

ZIP/Postal Code

146 24

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK 9000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Novartis Investigative Site

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Novartis Investigative Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Novartis Investigative Site

City

Svendborg

ZIP/Postal Code

5700

Country

Denmark

Facility Name

Novartis Investigative Site

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Viborg

ZIP/Postal Code

DK-8800

Country

Denmark

Facility Name

Novartis Investigative Site

City

Jyvaskyla

ZIP/Postal Code

40620

Country

Finland

Facility Name

Novartis Investigative Site

City

Kaupio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Novartis Investigative Site

City

Bron

ZIP/Postal Code

69677

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

Grenoble Cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Marseille Cedex 8

ZIP/Postal Code

13008

Country

France

Facility Name

Novartis Investigative Site

City

Paris cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Novartis Investigative Site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse Cedex

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Krozingen

ZIP/Postal Code

79189

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28277

Country

Germany

Facility Name

Novartis Investigative Site

City

Coburg

ZIP/Postal Code

96450

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Esslingen

ZIP/Postal Code

73730

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

65929

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Guetersloh

ZIP/Postal Code

33332

Country

Germany

Facility Name

Novartis Investigative Site

City

Hennigsdorf

ZIP/Postal Code

16761

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

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Langen

ZIP/Postal Code

63225

Country

Germany

Facility Name

Novartis Investigative Site

City

Leverkusen

ZIP/Postal Code

51375

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Novartis Investigative Site

City

Moenchengladbach

ZIP/Postal Code

41063

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuss

ZIP/Postal Code

41464

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuwied

ZIP/Postal Code

56564

Country

Germany

Facility Name

Novartis Investigative Site

City

Riesa

ZIP/Postal Code

01589

Country

Germany

Facility Name

Novartis Investigative Site

City

Ruesselsheim

ZIP/Postal Code

65428

Country

Germany

Facility Name

Novartis Investigative Site

City

Stadtlohn

ZIP/Postal Code

48703

Country

Germany

Facility Name

Novartis Investigative Site

City

Vechta

ZIP/Postal Code

49377

Country

Germany

Facility Name

Novartis Investigative Site

City

Villingen-Schwenningen

ZIP/Postal Code

78052

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58455

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Alexandroupolis

State/Province

Evros

ZIP/Postal Code

681 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

14233

Country

Greece

Facility Name

Novartis Investigative Site

City

Larissa

State/Province

ZIP/Postal Code

411 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

115 28

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Novartis Investigative Site

City

Pecs

State/Province

Baranya

ZIP/Postal Code

7621

Country

Hungary

Facility Name

Novartis Investigative Site

City

Zalaegerszeg

State/Province

Zala

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1027

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

Budapest

ZIP/Postal Code

H 1096

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekesfehervar

ZIP/Postal Code

H-8000

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

Karamsad

State/Province

Gujrat

ZIP/Postal Code

388325

Country

India

Facility Name

Novartis Investigative Site

City

Gurgaon

State/Province

Haryana

ZIP/Postal Code

122001

Country

India

Facility Name

Novartis Investigative Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682 018

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400012

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

Pune

State/Province

Maharashtra

ZIP/Postal Code

411001

Country

India

Facility Name

Novartis Investigative Site

City

Bikaner

State/Province

Rajasthan

ZIP/Postal Code

334003

Country

India

Facility Name

Novartis Investigative Site

City

Madurai

State/Province

Tamil NADU

ZIP/Postal Code

625107

Country

India

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500082

Country

India

Facility Name

Novartis Investigative Site

City

Secunderabad

State/Province

Telangana

ZIP/Postal Code

500003

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

3109601

Country

Israel

Facility Name

Novartis Investigative Site

City

Lower Galilee

ZIP/Postal Code

15208

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Sefad

ZIP/Postal Code

13100

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

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

40133

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Catanzaro

State/Province

ZIP/Postal Code

88100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cona

State/Province

ZIP/Postal Code

44121

Country

Italy

Facility Name

Novartis Investigative Site

City

Grosseto

State/Province

ZIP/Postal Code

58100

Country

Italy

Facility Name

Novartis Investigative Site

City

Sanremo

State/Province

ZIP/Postal Code

18038

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20138

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20142

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00184

Country

Italy

Facility Name

Novartis Investigative Site

City

Rimini

State/Province

ZIP/Postal Code

47900

Country

Italy

Facility Name

Novartis Investigative Site

City

Trieste

State/Province

ZIP/Postal Code

34149

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Cheongju si

State/Province

Chungcheongbuk Do

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Wonju

State/Province

Gangwon-do

ZIP/Postal Code

26427

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Torreon

State/Province

Coahulia

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Culiacan Sinaloa

State/Province

Distrito Federal

ZIP/Postal Code

80230

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44670

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

45116

Country

Mexico

Facility Name

Novartis Investigative Site

City

Ciudad de Mexico

ZIP/Postal Code

02980

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

78240

Country

Mexico

Facility Name

Novartis Investigative Site

City

Sneek

State/Province

The Netherlands

ZIP/Postal Code

8601 ZR

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Almelo

ZIP/Postal Code

7609 PP

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amersfoort

ZIP/Postal Code

3813 TZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1091AC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Beverwijk

ZIP/Postal Code

NL-1942 LE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Ede

ZIP/Postal Code

6716 RP

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

Heemstede

ZIP/Postal Code

2102 CW

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leiderdorp

ZIP/Postal Code

2353 GA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3083 AN

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Tilburg

ZIP/Postal Code

5042 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Uden

ZIP/Postal Code

5406 PT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Zutphen

ZIP/Postal Code

7207 AE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Gralum

ZIP/Postal Code

1714

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0372

Country

Norway

Facility Name

Novartis Investigative Site

City

Stavanger

ZIP/Postal Code

4068

Country

Norway

Facility Name

Novartis Investigative Site

City

Bellavista

State/Province

Lima

ZIP/Postal Code

CALLAO 02

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

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Iloilo city

State/Province

Iloilo

ZIP/Postal Code

5000

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

Manila

State/Province

Metro Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15 276

Country

Poland

Facility Name

Novartis Investigative Site

City

Lubin

ZIP/Postal Code

59-301

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-718

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Novartis Investigative Site

City

Carnaxide

State/Province

Lisboa

ZIP/Postal Code

2799 523

Country

Portugal

Facility Name

Novartis Investigative Site

City

Almada

ZIP/Postal Code

2801 951

Country

Portugal

Facility Name

Novartis Investigative Site

City

Braga

ZIP/Postal Code

4710243

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3041-853

Country

Portugal

Facility Name

Novartis Investigative Site

City

Covilha

ZIP/Postal Code

6200-251

Country

Portugal

Facility Name

Novartis Investigative Site

City

Faro

ZIP/Postal Code

8000 386

Country

Portugal

Facility Name

Novartis Investigative Site

City

Guimaraes

ZIP/Postal Code

4835 044

Country

Portugal

Facility Name

Novartis Investigative Site

City

Leiria

ZIP/Postal Code

2410-187

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Real

ZIP/Postal Code

5000-508

Country

Portugal

Facility Name

Novartis Investigative Site

City

Pitesti

State/Province

Arges

ZIP/Postal Code

110438

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

State/Province

District 4

ZIP/Postal Code

4204179

Country

Romania

Facility Name

Novartis Investigative Site

City

Oradea

State/Province

Jud Bihor

ZIP/Postal Code

410169

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

State/Province

Jud Cluj

ZIP/Postal Code

400001

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

State/Province

Jud Iasi

ZIP/Postal Code

700732

Country

Romania

Facility Name

Novartis Investigative Site

City

Targu Mures

State/Province

Mures

ZIP/Postal Code

540124

Country

Romania

Facility Name

Novartis Investigative Site

City

Braila

State/Province

ROM

ZIP/Postal Code

810249

Country

Romania

Facility Name

Novartis Investigative Site

City

Suceava

State/Province

ROM

ZIP/Postal Code

727525

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300362

Country

Romania

Facility Name

Novartis Investigative Site

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

022322

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

041915

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

050098

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

011461

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

014461

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

ZIP/Postal Code

200642

Country

Romania

Facility Name

Novartis Investigative Site

City

Sibiu

ZIP/Postal Code

550245

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

ZIP/Postal Code

300041

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

ZIP/Postal Code

300310

Country

Romania

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656038

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Krasnodar

ZIP/Postal Code

350086

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115516

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127644

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Murmansk

ZIP/Postal Code

183047

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

N.Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhnii Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Rostov on Don

ZIP/Postal Code

344068

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

S.-Petersburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sestroretsk

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sochy

ZIP/Postal Code

354057

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

191014

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

191015

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Tomsk

ZIP/Postal Code

634012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169609

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

768828

Country

Singapore

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

State/Province

Slovak Republic

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Banska Bystrica

State/Province

SVK

ZIP/Postal Code

974 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

833 48

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 11

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

081 81

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Pinelands

State/Province

Cape Town

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Novartis Investigative Site

City

George

State/Province

Western Cape

ZIP/Postal Code

6529

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Worcester

ZIP/Postal Code

6850

Country

South Africa

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41014

Country

Spain

Facility Name

Novartis Investigative Site

City

Villamartin

State/Province

Cadiz

ZIP/Postal Code

11650

Country

Spain

Facility Name

Novartis Investigative Site

City

Leon

State/Province

Castilla Y Leon

ZIP/Postal Code

24071

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceres

State/Province

Extremadura

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

A Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

La Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

State/Province

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Novartis Investigative Site

City

Goethenburg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Helsingborg

ZIP/Postal Code

252 20

Country

Sweden

Facility Name

Novartis Investigative Site

City

Helsingborg

ZIP/Postal Code

25232

Country

Sweden

Facility Name

Novartis Investigative Site

City

Malmo

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

118 83

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Vasteras

ZIP/Postal Code

72189

Country

Sweden

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lugano

ZIP/Postal Code

6903

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Luzern 16

ZIP/Postal Code

CH 6000

Country

Switzerland

Facility Name

Novartis Investigative Site

City

St Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

New Taipei

ZIP/Postal Code

22060

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Tainan

ZIP/Postal Code

71004

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Yilan

ZIP/Postal Code

26058

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bangkok

State/Province

THA

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Khon Kaen

State/Province

THA

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novartis Investigative Site

City

Meselik

State/Province

Eskisehir

ZIP/Postal Code

26480

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara-Cankaya

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34304

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34865

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kucukcekmece Istanbul

ZIP/Postal Code

34303

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33343

Country

Turkey

Facility Name

Novartis Investigative Site

City

Sivas

ZIP/Postal Code

58140

Country

Turkey

Facility Name

Novartis Investigative Site

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

Facility Name

Novartis Investigative Site

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Lincoln

State/Province

Lincolnshire

ZIP/Postal Code

LN2 5QY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Craigavon

State/Province

Northern Ireland

ZIP/Postal Code

BT63 5QQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Clydebank

State/Province

West Dumbartonshire

ZIP/Postal Code

G81 4HX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

ZIP/Postal Code

LS1 3EX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE3 9QP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Worcester

ZIP/Postal Code

WR5 1DD

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

36321459

Citation

Mehran R, Steg PG, Pfeffer MA, Jering K, Claggett B, Lewis EF, Granger C, Kober L, Maggioni A, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Ducrocq G, Berwanger O, De Pasquale CG, Landmesser U, Petrie M, Leng DSK, van der Meer P, Lefkowitz M, Zhou Y, Braunwald E. The Effects of Angiotensin Receptor-Neprilysin Inhibition on Major Coronary Events in Patients With Acute Myocardial Infarction: Insights From the PARADISE-MI Trial. Circulation. 2022 Dec 6;146(23):1749-1757. doi: 10.1161/CIRCULATIONAHA.122.060841. Epub 2022 Nov 2.

Results Reference

derived

PubMed Identifier

36082663

Citation

Shah AM, Claggett B, Prasad N, Li G, Volquez M, Jering K, Cikes M, Kovacs A, Mullens W, Nicolau JC, Kober L, van der Meer P, Jhund PS, Ibram G, Lefkowitz M, Zhou Y, Solomon SD, Pfeffer MA. Impact of Sacubitril/Valsartan Compared With Ramipril on Cardiac Structure and Function After Acute Myocardial Infarction: The PARADISE-MI Echocardiographic Substudy. Circulation. 2022 Oct 4;146(14):1067-1081. doi: 10.1161/CIRCULATIONAHA.122.059210. Epub 2022 Sep 9.

Results Reference

derived

PubMed Identifier

34797725

Citation

Pfeffer MA, Claggett B, Lewis EF, Granger CB, Kober L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, Fernandez A, Filippatos G, Jering K, Landmesser U, Menon V, Merkely B, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Wang Y, Braunwald E. Impact of Sacubitril/Valsartan Versus Ramipril on Total Heart Failure Events in the PARADISE-MI Trial. Circulation. 2022 Jan 4;145(1):87-89. doi: 10.1161/CIRCULATIONAHA.121.057429. Epub 2021 Nov 19. No abstract available.

Results Reference

derived

PubMed Identifier

34758252

Citation

Pfeffer MA, Claggett B, Lewis EF, Granger CB, Kober L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, East C, Fernandez A, Jering K, Landmesser U, Mehran R, Merkely B, Vaghaiwalla Mody F, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Gong J, Braunwald E; PARADISE-MI Investigators and Committees. Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction. N Engl J Med. 2021 Nov 11;385(20):1845-1855. doi: 10.1056/NEJMoa2104508. Erratum In: N Engl J Med. 2021 Dec 30;385(27):2592.

Results Reference

derived

Learn more about this trial

Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

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Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI (PARADISE-MI)

Acute Myocardial Infarction

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