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Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT)

Primary Purpose

Acute Decompensated Heart Failure, Congestive Heart Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aliskiren
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring elevated BNP, reduced LVEF, Acute Heart Failure, Cardiovascular death, CHF, hospitalization, morbi-mortality trial, outcome study, endpoint driven, plasma renin activity, renin angiotensin, aldosterone system, direct renin inhibitors, BNP, KCCQ, eGFR

Eligibility Criteria

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

Inclusion criteria:

  • Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female.
  • Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.

    • LVEF < 40% (measured within the last 6 months).
    • Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization.
  • Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml).
  • Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).

Exclusion Criteria:

  • Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
  • Concomitant use of ACEI and ARB at randomization.
  • Right heart failure due to pulmonary disease.
  • Diagnosis of postpartum cardiomyopathy.
  • Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
  • Patients with a history of heart transplant or who are on a transplant list.
  • Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.

Other protocol-defined inclusion/exclusion criteria applied.

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aliskiren

Placebo

Arm Description

Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.

Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.

Outcomes

Primary Outcome Measures

Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.

Secondary Outcome Measures

Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.
Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.

Full Information

First Posted
May 5, 2009
Last Updated
October 15, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00894387
Brief Title
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Acronym
ASTRONAUT
Official Title
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure, Congestive Heart Failure
Keywords
elevated BNP, reduced LVEF, Acute Heart Failure, Cardiovascular death, CHF, hospitalization, morbi-mortality trial, outcome study, endpoint driven, plasma renin activity, renin angiotensin, aldosterone system, direct renin inhibitors, BNP, KCCQ, eGFR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1639 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aliskiren
Arm Type
Experimental
Arm Description
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Aliskiren®,, Tekturna®,, Rasilez®,, SPP100
Intervention Description
Aliskiren 150 mg and Aliskiren 300 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
Description
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Description
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.
Time Frame
12 months
Title
Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
Description
Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.
Time Frame
Baseline, 1 months, 6 months and 12 months
Title
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Description
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Time Frame
6 months
Title
Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
Time Frame
12 months
Title
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Description
The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.
Time Frame
Baseline, 1 month, 6 months and 12 months
Title
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Description
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female. Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization. LVEF < 40% (measured within the last 6 months). Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization. Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml). Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV). Exclusion Criteria: Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization. Concomitant use of ACEI and ARB at randomization. Right heart failure due to pulmonary disease. Diagnosis of postpartum cardiomyopathy. Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months. Patients with a history of heart transplant or who are on a transplant list. Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization. Other protocol-defined inclusion/exclusion criteria applied.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723-0001
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Novartis Investigative Site
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Novartis Investigative Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Facility Name
Novartis Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2975
Country
United States
Facility Name
Novartis Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Novartis Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Novartis Investigative Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Novartis Investigative Site
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Novartis Investigative Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States
Facility Name
Novartis Investigative Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70501
Country
United States
Facility Name
Novartis Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Novartis Investigative Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Novartis Investigative Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Novartis Investigative Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Novartis Investigative Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103-2714
Country
United States
Facility Name
Novartis Investigative Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Novartis Investigative Site
City
Saratoga Springs
State/Province
New York
ZIP/Postal Code
12866
Country
United States
Facility Name
Novartis Investigative Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7075
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Novartis Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Novartis Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Novartis Investigative Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Novartis Investigative Site
City
Springfield
State/Province
Tennessee
ZIP/Postal Code
37172
Country
United States
Facility Name
Novartis Investigative Site
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Name
Novartis Investigative Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Novartis Investigative Site
City
San Nicolas
State/Province
Buenos Aires
ZIP/Postal Code
B2900IIC
Country
Argentina
Facility Name
Novartis Investigative Site
City
Posadas
State/Province
Misiones
ZIP/Postal Code
N3300AHX
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2001ODA
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000JCU
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
B1650CSQ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
B1708KCH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1050AAK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1094AAD
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1201AAO
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos aires
ZIP/Postal Code
C1210AAP
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
W3400ABH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5000AAI
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5006IKK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Novartis Investigative Site
City
Corrientes
ZIP/Postal Code
W3400CBI
Country
Argentina
Facility Name
Novartis Investigative Site
City
Corrientes
ZIP/Postal Code
W3400
Country
Argentina
Facility Name
Novartis Investigative Site
City
Quilmes
ZIP/Postal Code
1878
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
S2004CMW
Country
Argentina
Facility Name
Novartis Investigative Site
City
Tucuman
ZIP/Postal Code
T4000NIJ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Antwerpen
ZIP/Postal Code
2020
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
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Novartis Investigative Site
City
Huy
ZIP/Postal Code
4500
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Novartis Investigative Site
City
Mol
ZIP/Postal Code
2400
Country
Belgium
Facility Name
Novartis Investigative Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
20180-090
Country
Brazil
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Novartis Investigative Site
City
Londrina
State/Province
PR
ZIP/Postal Code
86051-990
Country
Brazil
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22261-010
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Campinas
State/Province
SP
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15150-210
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
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
H3A 1A1
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
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Facility Name
Novartis Investigative Site
City
Barranquilla
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
Country
Colombia
Facility Name
Novartis Investigative Site
City
Cali
Country
Colombia
Facility Name
Novartis Investigative Site
City
Florida Blanca
Country
Colombia
Facility Name
Novartis Investigative Site
City
Hradec Kralove
State/Province
CZE
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Brno - Bohunice
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Brno
ZIP/Postal Code
636 00
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Prague 4
ZIP/Postal Code
146 24
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Prague 5
ZIP/Postal Code
150 00
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Slany
ZIP/Postal Code
27401
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Teplice
ZIP/Postal Code
415 29
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Znojmo
ZIP/Postal Code
669 02
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Jyvaskyla
ZIP/Postal Code
FIN-40620
Country
Finland
Facility Name
Novartis Investigative Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Facility Name
Novartis Investigative Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Novartis Investigative Site
City
Le Chesnay
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Novartis Investigative Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Novartis Investigative Site
City
Pontoise
ZIP/Postal Code
F-95300
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
86156
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Bevensen
ZIP/Postal Code
29549
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12621
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13578
Country
Germany
Facility Name
Novartis Investigative Site
City
Bischofswerda
ZIP/Postal Code
01877
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Novartis Investigative Site
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Novartis Investigative Site
City
Cloppenburg
ZIP/Postal Code
49661
Country
Germany
Facility Name
Novartis Investigative Site
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Novartis Investigative Site
City
Dessau
ZIP/Postal Code
D-06822
Country
Germany
Facility Name
Novartis Investigative Site
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
Novartis Investigative Site
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60316
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Novartis Investigative Site
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Novartis Investigative Site
City
Halle/'Saale
ZIP/Postal Code
06120
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Novartis Investigative Site
City
Herrsching
ZIP/Postal Code
82211
Country
Germany
Facility Name
Novartis Investigative Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Novartis Investigative Site
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Novartis Investigative Site
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Novartis Investigative Site
City
Langen
ZIP/Postal Code
63225
Country
Germany
Facility Name
Novartis Investigative Site
City
Ludwigslust
ZIP/Postal Code
19288
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Novartis Investigative Site
City
Merseburg
ZIP/Postal Code
06217
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novartis Investigative Site
City
Nordhorn
ZIP/Postal Code
48527
Country
Germany
Facility Name
Novartis Investigative Site
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Novartis Investigative Site
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Novartis Investigative Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Novartis Investigative Site
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Novartis Investigative Site
City
Sömmerda
ZIP/Postal Code
99610
Country
Germany
Facility Name
Novartis Investigative Site
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Novartis Investigative Site
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Novartis Investigative Site
City
Balatonfured
ZIP/Postal Code
H-8231
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
1096
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
H-1106
Country
Hungary
Facility Name
Novartis Investigative Site
City
Hodmezovasarhely
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Novartis Investigative Site
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szolnok
ZIP/Postal Code
H-5000
Country
Hungary
Facility Name
Novartis Investigative Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Novartis Investigative Site
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Novartis Investigative Site
City
Vadodara
State/Province
Gujrat
ZIP/Postal Code
390015
Country
India
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 069
Country
India
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Facility Name
Novartis Investigative Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575002
Country
India
Facility Name
Novartis Investigative Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682 026
Country
India
Facility Name
Novartis Investigative Site
City
Indore
State/Province
M.p.
ZIP/Postal Code
452001
Country
India
Facility Name
Novartis Investigative Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 022
Country
India
Facility Name
Novartis Investigative Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Novartis Investigative Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Novartis Investigative Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Novartis Investigative Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Novartis Investigative Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641014
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641037
Country
India
Facility Name
Novartis Investigative Site
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
Novartis Investigative Site
City
Hyderabad
ZIP/Postal Code
500 063
Country
India
Facility Name
Novartis Investigative Site
City
New Delhi
ZIP/Postal Code
110 025
Country
India
Facility Name
Novartis Investigative Site
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Novartis Investigative Site
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novartis Investigative Site
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Novartis Investigative Site
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Novartis Investigative Site
City
Pavia
State/Province
(pv)
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
(vr)
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
Novartis Investigative Site
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
Novartis Investigative Site
City
Catania
State/Province
CT
ZIP/Postal Code
95123
Country
Italy
Facility Name
Novartis Investigative Site
City
Lagosanto
State/Province
FE
ZIP/Postal Code
44023
Country
Italy
Facility Name
Novartis Investigative Site
City
Foggia
State/Province
FG
ZIP/Postal Code
71100
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50141
Country
Italy
Facility Name
Novartis Investigative Site
City
Grosseto
State/Province
GR
ZIP/Postal Code
58100
Country
Italy
Facility Name
Novartis Investigative Site
City
Pozzilli
State/Province
IS
ZIP/Postal Code
86077
Country
Italy
Facility Name
Novartis Investigative Site
City
Casarano
State/Province
LE
ZIP/Postal Code
73042
Country
Italy
Facility Name
Novartis Investigative Site
City
Lecce
State/Province
LE
ZIP/Postal Code
73100
Country
Italy
Facility Name
Novartis Investigative Site
City
Scorrano
State/Province
LE
ZIP/Postal Code
73020
Country
Italy
Facility Name
Novartis Investigative Site
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Facility Name
Novartis Investigative Site
City
Legnano
State/Province
MI
ZIP/Postal Code
20025
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20157
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
State/Province
PG
ZIP/Postal Code
06129
Country
Italy
Facility Name
Novartis Investigative Site
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novartis Investigative Site
City
Albano Laziale
State/Province
RM
ZIP/Postal Code
00041
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00185
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00189
Country
Italy
Facility Name
Novartis Investigative Site
City
Rimini
State/Province
RN
ZIP/Postal Code
47900
Country
Italy
Facility Name
Novartis Investigative Site
City
Siena
State/Province
SI
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novartis Investigative Site
City
Legnago
State/Province
VR
ZIP/Postal Code
37045
Country
Italy
Facility Name
Novartis Investigative Site
City
Quezon City
State/Province
Metro Manila
ZIP/Postal Code
1109
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
Grodzisk Wielkopolski
ZIP/Postal Code
62-065
Country
Poland
Facility Name
Novartis Investigative Site
City
Klodzko
ZIP/Postal Code
57-300
Country
Poland
Facility Name
Novartis Investigative Site
City
Kraków
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Novartis Investigative Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Novartis Investigative Site
City
Lódz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Novartis Investigative Site
City
Ruda Slaska
ZIP/Postal Code
41-703
Country
Poland
Facility Name
Novartis Investigative Site
City
Swidnica
ZIP/Postal Code
58-100
Country
Poland
Facility Name
Novartis Investigative Site
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Novartis Investigative Site
City
Walbrzych
ZIP/Postal Code
58-309
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Novartis Investigative Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novartis Investigative Site
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Novartis Investigative Site
City
Bucuresti
State/Province
District 1
ZIP/Postal Code
014461
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
021659
Country
Romania
Facility Name
Novartis Investigative Site
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Novartis Investigative Site
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Novartis Investigative Site
City
Tirgoviste
ZIP/Postal Code
130083
Country
Romania
Facility Name
Novartis Investigative Site
City
Lubertsi
ZIP/Postal Code
140006
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
109377
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115487
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119881
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
127473
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhnii Novgorod
ZIP/Postal Code
603000
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
S.-Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
S.-Petersburg
ZIP/Postal Code
195197
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
S.-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
S.-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint-Petersburg
ZIP/Postal Code
193312
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
198013
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Sankt-Peterburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St.Petersburg
ZIP/Postal Code
193163
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
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
168752
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
768825
Country
Singapore
Facility Name
Novartis Investigative Site
City
Liptovsky Mikulas
State/Province
Slovak Republic
ZIP/Postal Code
831 23
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Presov
State/Province
Slovak Republic
ZIP/Postal Code
081 81
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Komarno
ZIP/Postal Code
94575
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice-Saca
ZIP/Postal Code
040 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
Lucenec
ZIP/Postal Code
984 39
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Sanlúcar de Barrameda
State/Province
Andalucia
ZIP/Postal Code
11540
Country
Spain
Facility Name
Novartis Investigative Site
City
Villamartin
State/Province
Andalucia
ZIP/Postal Code
11650
Country
Spain
Facility Name
Novartis Investigative Site
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08003
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novartis Investigative Site
City
Majadanonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Novartis Investigative Site
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Novartis Investigative Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Keelung City
ZIP/Postal Code
20401
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Lin-Ko
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Novartis Investigative Site
City
Atakum / Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Novartis Investigative Site
City
Etlik / Ankara
ZIP/Postal Code
06018
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34304
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
Kirikkale
ZIP/Postal Code
71100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Novartis Investigative Site
City
Sivas
ZIP/Postal Code
58140
Country
Turkey
Facility Name
Novartis Investigative Site
City
Talas / Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
29143416
Citation
Vaduganathan M, Cheema B, Cleveland E, Sankar K, Subacius H, Fonarow GC, Solomon SD, Lewis EF, Greene SJ, Maggioni AP, Bohm M, Zannad F, Butler J, Gheorghiade M. Plasma renin activity, response to aliskiren, and clinical outcomes in patients hospitalized for heart failure: the ASTRONAUT trial. Eur J Heart Fail. 2018 Apr;20(4):677-686. doi: 10.1002/ejhf.973. Epub 2017 Nov 16.
Results Reference
derived
PubMed Identifier
29044915
Citation
Greene SJ, Butler J, Fonarow GC, Subacius HP, Ambrosy AP, Vaduganathan M, Triggiani M, Solomon SD, Lewis EF, Maggioni AP, Bohm M, Chioncel O, Nodari S, Senni M, Zannad F, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Pre-discharge and early post-discharge troponin elevation among patients hospitalized for heart failure with reduced ejection fraction: findings from the ASTRONAUT trial. Eur J Heart Fail. 2018 Feb;20(2):281-291. doi: 10.1002/ejhf.1019. Epub 2017 Oct 17.
Results Reference
derived
PubMed Identifier
28960673
Citation
Lund LH, Trochu JN, Meyns B, Caliskan K, Shaw S, Schmitto JD, Schibilsky D, Damme L, Heatley J, Gustafsson F. Screening for heart transplantation and left ventricular assist system: results from the ScrEEning for advanced Heart Failure treatment (SEE-HF) study. Eur J Heart Fail. 2018 Jan;20(1):152-160. doi: 10.1002/ejhf.975. Epub 2017 Sep 27.
Results Reference
derived
PubMed Identifier
23478743
Citation
Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954. Erratum In: JAMA. 2013 Apr 10;309(14):1461.
Results Reference
derived
PubMed Identifier
21123186
Citation
Gheorghiade M, Albaghdadi M, Zannad F, Fonarow GC, Bohm M, Gimpelewicz C, Botha J, Moores S, Lewis EF, Rattunde H, Maggioni A; ASTRONAUT investigators and study coordinators. Rationale and design of the multicentre, randomized, double-blind, placebo-controlled Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT). Eur J Heart Fail. 2011 Jan;13(1):100-6. doi: 10.1093/eurjhf/hfq209. Epub 2010 Nov 30.
Results Reference
derived

Learn more about this trial

Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

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