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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00853658




Registration number
NCT00853658
Ethics application status
Date submitted
26/02/2009
Date registered
2/03/2009
Date last updated
25/11/2016

Titles & IDs
Public title
Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
Scientific title
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).
Secondary ID [1] 0 0
2008-004104-31
Secondary ID [2] 0 0
CSPP100F2301
Universal Trial Number (UTN)
Trial acronym
ATMOSPHERE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enalapril
Treatment: Drugs - Aliskiren

Experimental: Combination Aliskiren / Enalapril - Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.

Experimental: Aliskiren - Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.

Active Comparator: Enalapril - Enalapril monotherapy -10 mg film-coated tablet and administered orally.


Treatment: Drugs: Enalapril
Enalapril 10 mg film-coated tablet and administered orally.

Treatment: Drugs: Aliskiren
Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Timepoint [1] 0 0
up to End of Study (78 months)
Secondary outcome [1] 0 0
Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Timepoint [1] 0 0
Baseline, Month 12
Secondary outcome [2] 0 0
All Cause Death
Timepoint [2] 0 0
up to end of study (78 months)

Eligibility
Key inclusion criteria
Inclusion Criteria

Patients eligible for inclusion in this study had to fulfill all of the following criteria:

1. Patients = 18 years of age, male or female.

2. Patients with a diagnosis of chronic heart failure (NYHA

Class II - IV):

1. LVEF = 35% at Visit 1 (local measurement, within the past 6 months assessed by
echocardiography, multiple uptake gated acquisition scan (MUGA), computerized
tomography(CT) scan, magnetic resonance imaging (MRI) or ventricular angiography)

2. Elevated BNP or NT-proBNP at Visit 1:

BNP = 150 pg/mL (or BNP = 100 pg/mL and unplanned hospitalization for HF within the
last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP = 600
pg/mL (or NT-proBNP = 400 pg/mL and unplanned hospitalization for HF within the last
12 months prior to Visit 1) (according to local measurement).

3. Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at
least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril,
perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to
Visit 1

4. Patients had to be treated with a beta-blocker, unless contraindicated or not
tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not on
target dose, according to local guidelines, or in absence of that medication, the
reason should be documented).

5. Written informed consent to participate in the study and ability to comply with all
requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Patients with any of the following were to be excluded from participation in the study:

1. History of hypersensitivity to any of the study drugs including history or allergy to
ACEIs as well as known or suspected contraindications to the study drugs or previous
history of intolerance to high doses of ACEIs during up- titration process.

2. Patients treated concomitantly with both an ARB and an aldosterone antagonist in
addition to study drug at Visit 1.

3. Current acute decompensated HF (defined as an acute exacerbation of a chronic heart
failure status manifested by typical signs and symptoms of HF like dyspnea, fatigue
etc., that may require IV therapy with diuretics, vasodilators and/or inotropic
drugs).

4. Symptomatic hypotension and/or less than 95 mmHg systolic blood pressure (SBP) at
Visit 1 and/or less than 90 mmHg SBP at Visit 4.

5. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major
vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty,
within the past 3 months prior to Visit 1.

6. Coronary or carotid artery disease likely to require surgical or percutaneous
intervention within the 6 months after Visit 1.

7. Right heart failure due to severe pulmonary disease.

8. Patients with Diabetes Mellitus.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
7064
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Canberra
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Novartis Investigative Site - Darlinghurst
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Novartis Investigative Site - Kingswood
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Novartis Investigative Site - Wollongong
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Novartis Investigative Site - Auchenflower
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Novartis Investigative Site - Woolloongabba
Recruitment hospital [7] 0 0
Novartis Investigative Site - Wooloongabba
Recruitment hospital [8] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [9] 0 0
Novartis Investigative Site - Launceston
Recruitment hospital [10] 0 0
Novartis Investigative Site - Geelong
Recruitment hospital [11] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
4101 - Woolloongabba
Recruitment postcode(s) [7] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
7250 - Launceston
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
3181 - Prahran
Recruitment outside Australia
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Germany
State/province [207] 0 0
Muehlheim an der Ruhr
Country [208] 0 0
Germany
State/province [208] 0 0
Muenchen
Country [209] 0 0
Germany
State/province [209] 0 0
Mülheim
Country [210] 0 0
Germany
State/province [210] 0 0
Northeim
Country [211] 0 0
Germany
State/province [211] 0 0
Nürnberg
Country [212] 0 0
Germany
State/province [212] 0 0
Oelde
Country [213] 0 0
Germany
State/province [213] 0 0
Pirna
Country [214] 0 0
Germany
State/province [214] 0 0
Potsdam
Country [215] 0 0
Germany
State/province [215] 0 0
Reinfeld
Country [216] 0 0
Germany
State/province [216] 0 0
Salzwedel
Country [217] 0 0
Germany
State/province [217] 0 0
Schwalmstadt
Country [218] 0 0
Germany
State/province [218] 0 0
Schwäbisch Hall
Country [219] 0 0
Germany
State/province [219] 0 0
Siegen
Country [220] 0 0
Germany
State/province [220] 0 0
Solingen
Country [221] 0 0
Germany
State/province [221] 0 0
Stade
Country [222] 0 0
Germany
State/province [222] 0 0
Stuttgart
Country [223] 0 0
Germany
State/province [223] 0 0
Wedel
Country [224] 0 0
Germany
State/province [224] 0 0
Witten
Country [225] 0 0
Germany
State/province [225] 0 0
Wuerzburg
Country [226] 0 0
Germany
State/province [226] 0 0
Zwickau
Country [227] 0 0
Greece
State/province [227] 0 0
GR
Country [228] 0 0
Greece
State/province [228] 0 0
Athens
Country [229] 0 0
Greece
State/province [229] 0 0
Chios
Country [230] 0 0
Greece
State/province [230] 0 0
Edessa
Country [231] 0 0
India
State/province [231] 0 0
Andhra Pradesh
Country [232] 0 0
India
State/province [232] 0 0
Delhi
Country [233] 0 0
India
State/province [233] 0 0
Gujarat
Country [234] 0 0
India
State/province [234] 0 0
Karnataka
Country [235] 0 0
India
State/province [235] 0 0
Kerela
Country [236] 0 0
India
State/province [236] 0 0
Maharashtra
Country [237] 0 0
India
State/province [237] 0 0
New Delhi
Country [238] 0 0
India
State/province [238] 0 0
Rajasthan
Country [239] 0 0
India
State/province [239] 0 0
Tamil Nadu
Country [240] 0 0
India
State/province [240] 0 0
Telangana
Country [241] 0 0
India
State/province [241] 0 0
Uttar Pradesh
Country [242] 0 0
India
State/province [242] 0 0
Bangalore
Country [243] 0 0
India
State/province [243] 0 0
Hyderabad
Country [244] 0 0
India
State/province [244] 0 0
Lucknow
Country [245] 0 0
India
State/province [245] 0 0
Mumbai
Country [246] 0 0
India
State/province [246] 0 0
Noida
Country [247] 0 0
Ireland
State/province [247] 0 0
Co Dublin
Country [248] 0 0
Ireland
State/province [248] 0 0
Dublin 7
Country [249] 0 0
Ireland
State/province [249] 0 0
Dublin
Country [250] 0 0
Ireland
State/province [250] 0 0
Galway
Country [251] 0 0
Italy
State/province [251] 0 0
(pv)
Country [252] 0 0
Italy
State/province [252] 0 0
AN
Country [253] 0 0
Italy
State/province [253] 0 0
AR
Country [254] 0 0
Italy
State/province [254] 0 0
BG
Country [255] 0 0
Italy
State/province [255] 0 0
BO
Country [256] 0 0
Italy
State/province [256] 0 0
BS
Country [257] 0 0
Italy
State/province [257] 0 0
CH
Country [258] 0 0
Italy
State/province [258] 0 0
CS
Country [259] 0 0
Italy
State/province [259] 0 0
FC
Country [260] 0 0
Italy
State/province [260] 0 0
FE
Country [261] 0 0
Italy
State/province [261] 0 0
FG
Country [262] 0 0
Italy
State/province [262] 0 0
FI
Country [263] 0 0
Italy
State/province [263] 0 0
IS
Country [264] 0 0
Italy
State/province [264] 0 0
LE
Country [265] 0 0
Italy
State/province [265] 0 0
LI
Country [266] 0 0
Italy
State/province [266] 0 0
LU
Country [267] 0 0
Italy
State/province [267] 0 0
MI
Country [268] 0 0
Italy
State/province [268] 0 0
MN
Country [269] 0 0
Italy
State/province [269] 0 0
MS
Country [270] 0 0
Italy
State/province [270] 0 0
PA
Country [271] 0 0
Italy
State/province [271] 0 0
PG
Country [272] 0 0
Italy
State/province [272] 0 0
PR
Country [273] 0 0
Italy
State/province [273] 0 0
PV
Country [274] 0 0
Italy
State/province [274] 0 0
RA
Country [275] 0 0
Italy
State/province [275] 0 0
RM
Country [276] 0 0
Italy
State/province [276] 0 0
RN
Country [277] 0 0
Italy
State/province [277] 0 0
SA
Country [278] 0 0
Italy
State/province [278] 0 0
SI
Country [279] 0 0
Italy
State/province [279] 0 0
SO
Country [280] 0 0
Italy
State/province [280] 0 0
SP
Country [281] 0 0
Italy
State/province [281] 0 0
SS
Country [282] 0 0
Italy
State/province [282] 0 0
TO
Country [283] 0 0
Italy
State/province [283] 0 0
TR
Country [284] 0 0
Italy
State/province [284] 0 0
TS
Country [285] 0 0
Italy
State/province [285] 0 0
TV
Country [286] 0 0
Italy
State/province [286] 0 0
UD
Country [287] 0 0
Italy
State/province [287] 0 0
VA
Country [288] 0 0
Italy
State/province [288] 0 0
VR
Country [289] 0 0
Japan
State/province [289] 0 0
Aichi
Country [290] 0 0
Japan
State/province [290] 0 0
Chiba
Country [291] 0 0
Japan
State/province [291] 0 0
Fukuoka
Country [292] 0 0
Japan
State/province [292] 0 0
Gifu
Country [293] 0 0
Japan
State/province [293] 0 0
Hiroshima
Country [294] 0 0
Japan
State/province [294] 0 0
Hokkaido
Country [295] 0 0
Japan
State/province [295] 0 0
Hyogo
Country [296] 0 0
Japan
State/province [296] 0 0
Ibaraki
Country [297] 0 0
Japan
State/province [297] 0 0
Ishikawa
Country [298] 0 0
Japan
State/province [298] 0 0
Kanagawa
Country [299] 0 0
Japan
State/province [299] 0 0
Kumamoto
Country [300] 0 0
Japan
State/province [300] 0 0
Miyagi
Country [301] 0 0
Japan
State/province [301] 0 0
Nara
Country [302] 0 0
Japan
State/province [302] 0 0
Okayama
Country [303] 0 0
Japan
State/province [303] 0 0
Osaka
Country [304] 0 0
Japan
State/province [304] 0 0
Saga
Country [305] 0 0
Japan
State/province [305] 0 0
Shimane
Country [306] 0 0
Japan
State/province [306] 0 0
Tokushima
Country [307] 0 0
Japan
State/province [307] 0 0
Tokyo
Country [308] 0 0
Japan
State/province [308] 0 0
Yamaguchi
Country [309] 0 0
Japan
State/province [309] 0 0
Fukushima
Country [310] 0 0
Japan
State/province [310] 0 0
Nagasaki
Country [311] 0 0
Japan
State/province [311] 0 0
Toyama
Country [312] 0 0
Korea, Republic of
State/province [312] 0 0
Gyeonggi
Country [313] 0 0
Korea, Republic of
State/province [313] 0 0
Korea
Country [314] 0 0
Korea, Republic of
State/province [314] 0 0
Busan
Country [315] 0 0
Korea, Republic of
State/province [315] 0 0
Daejeon
Country [316] 0 0
Korea, Republic of
State/province [316] 0 0
Gwangju
Country [317] 0 0
Korea, Republic of
State/province [317] 0 0
Incheon
Country [318] 0 0
Korea, Republic of
State/province [318] 0 0
Seoul
Country [319] 0 0
Korea, Republic of
State/province [319] 0 0
Taegu
Country [320] 0 0
Latvia
State/province [320] 0 0
Daugavpils
Country [321] 0 0
Latvia
State/province [321] 0 0
Riga
Country [322] 0 0
Lithuania
State/province [322] 0 0
LTU
Country [323] 0 0
Lithuania
State/province [323] 0 0
Kaunas
Country [324] 0 0
Lithuania
State/province [324] 0 0
Klaipeda
Country [325] 0 0
Lithuania
State/province [325] 0 0
Vilnius
Country [326] 0 0
Mexico
State/province [326] 0 0
Jalisco
Country [327] 0 0
Mexico
State/province [327] 0 0
Nuevo León
Country [328] 0 0
Mexico
State/province [328] 0 0
Sinaloa
Country [329] 0 0
Mexico
State/province [329] 0 0
Aguascalientes
Country [330] 0 0
Mexico
State/province [330] 0 0
Querétaro
Country [331] 0 0
Mexico
State/province [331] 0 0
San Luis Potosi
Country [332] 0 0
Netherlands
State/province [332] 0 0
Alkmaar
Country [333] 0 0
Netherlands
State/province [333] 0 0
Amsterdam
Country [334] 0 0
Netherlands
State/province [334] 0 0
Apeldoorn
Country [335] 0 0
Netherlands
State/province [335] 0 0
Deventer
Country [336] 0 0
Netherlands
State/province [336] 0 0
Dirksland
Country [337] 0 0
Netherlands
State/province [337] 0 0
Enschede
Country [338] 0 0
Netherlands
State/province [338] 0 0
Groningen
Country [339] 0 0
Netherlands
State/province [339] 0 0
Haarlem
Country [340] 0 0
Netherlands
State/province [340] 0 0
Heerlen
Country [341] 0 0
Netherlands
State/province [341] 0 0
Leeuwarden
Country [342] 0 0
Netherlands
State/province [342] 0 0
Leiderdorp
Country [343] 0 0
Netherlands
State/province [343] 0 0
Meppel
Country [344] 0 0
Netherlands
State/province [344] 0 0
Rotterdam
Country [345] 0 0
Netherlands
State/province [345] 0 0
Venlo
Country [346] 0 0
Netherlands
State/province [346] 0 0
Wildervank
Country [347] 0 0
Netherlands
State/province [347] 0 0
Zutphen
Country [348] 0 0
Netherlands
State/province [348] 0 0
Zwolle
Country [349] 0 0
Norway
State/province [349] 0 0
Oslo
Country [350] 0 0
Norway
State/province [350] 0 0
Trondheim
Country [351] 0 0
Norway
State/province [351] 0 0
Tønsberg
Country [352] 0 0
Peru
State/province [352] 0 0
La Libertad
Country [353] 0 0
Peru
State/province [353] 0 0
Lambayeque
Country [354] 0 0
Peru
State/province [354] 0 0
Lima
Country [355] 0 0
Poland
State/province [355] 0 0
Bytom
Country [356] 0 0
Poland
State/province [356] 0 0
Chorzow
Country [357] 0 0
Poland
State/province [357] 0 0
Gdansk
Country [358] 0 0
Poland
State/province [358] 0 0
Gdynia
Country [359] 0 0
Poland
State/province [359] 0 0
Gliwice
Country [360] 0 0
Poland
State/province [360] 0 0
Grodzisk Mazowiecki
Country [361] 0 0
Poland
State/province [361] 0 0
Katowice
Country [362] 0 0
Poland
State/province [362] 0 0
Klodzko
Country [363] 0 0
Poland
State/province [363] 0 0
Krakow
Country [364] 0 0
Poland
State/province [364] 0 0
Kraków
Country [365] 0 0
Poland
State/province [365] 0 0
Lomza
Country [366] 0 0
Poland
State/province [366] 0 0
Olawa
Country [367] 0 0
Poland
State/province [367] 0 0
Opole
Country [368] 0 0
Poland
State/province [368] 0 0
Ostrow Wielkopolski
Country [369] 0 0
Poland
State/province [369] 0 0
Ostrowiec Swietokrzyski
Country [370] 0 0
Poland
State/province [370] 0 0
Piotrkow Trybunalski
Country [371] 0 0
Poland
State/province [371] 0 0
Plock
Country [372] 0 0
Poland
State/province [372] 0 0
Poznan
Country [373] 0 0
Poland
State/province [373] 0 0
Sandomierz
Country [374] 0 0
Poland
State/province [374] 0 0
Tarnow
Country [375] 0 0
Poland
State/province [375] 0 0
Torun
Country [376] 0 0
Poland
State/province [376] 0 0
Warszawa
Country [377] 0 0
Poland
State/province [377] 0 0
Wroclaw
Country [378] 0 0
Poland
State/province [378] 0 0
Zabrze
Country [379] 0 0
Portugal
State/province [379] 0 0
Amadora
Country [380] 0 0
Portugal
State/province [380] 0 0
Aveiro
Country [381] 0 0
Portugal
State/province [381] 0 0
Carnaxide
Country [382] 0 0
Portugal
State/province [382] 0 0
Coimbra
Country [383] 0 0
Portugal
State/province [383] 0 0
Faro
Country [384] 0 0
Portugal
State/province [384] 0 0
Lisboa
Country [385] 0 0
Portugal
State/province [385] 0 0
Penafiel
Country [386] 0 0
Portugal
State/province [386] 0 0
Porto
Country [387] 0 0
Puerto Rico
State/province [387] 0 0
Humacao
Country [388] 0 0
Puerto Rico
State/province [388] 0 0
Ponce
Country [389] 0 0
Puerto Rico
State/province [389] 0 0
San Juan
Country [390] 0 0
Romania
State/province [390] 0 0
District 1
Country [391] 0 0
Romania
State/province [391] 0 0
District 2
Country [392] 0 0
Romania
State/province [392] 0 0
Jud Iasi
Country [393] 0 0
Romania
State/province [393] 0 0
jud Mures
Country [394] 0 0
Romania
State/province [394] 0 0
Jud. Iasi
Country [395] 0 0
Romania
State/province [395] 0 0
Mures
Country [396] 0 0
Romania
State/province [396] 0 0
Baia Mare
Country [397] 0 0
Romania
State/province [397] 0 0
Brasov
Country [398] 0 0
Romania
State/province [398] 0 0
Cluj Napoca
Country [399] 0 0
Romania
State/province [399] 0 0
Cluj-Napoca
Country [400] 0 0
Romania
State/province [400] 0 0
Iasi
Country [401] 0 0
Romania
State/province [401] 0 0
Oradea
Country [402] 0 0
Romania
State/province [402] 0 0
Pitesti
Country [403] 0 0
Romania
State/province [403] 0 0
Targu Mures
Country [404] 0 0
Romania
State/province [404] 0 0
Timisoara
Country [405] 0 0
Russian Federation
State/province [405] 0 0
Barnaul
Country [406] 0 0
Russian Federation
State/province [406] 0 0
Chelyabinsk
Country [407] 0 0
Russian Federation
State/province [407] 0 0
Ekaterinburg
Country [408] 0 0
Russian Federation
State/province [408] 0 0
Izhevsk
Country [409] 0 0
Russian Federation
State/province [409] 0 0
Kirov
Country [410] 0 0
Russian Federation
State/province [410] 0 0
Krasnodar
Country [411] 0 0
Russian Federation
State/province [411] 0 0
Kursk
Country [412] 0 0
Russian Federation
State/province [412] 0 0
Lubertsi
Country [413] 0 0
Russian Federation
State/province [413] 0 0
Moscow
Country [414] 0 0
Russian Federation
State/province [414] 0 0
Nizhny Novgorod
Country [415] 0 0
Russian Federation
State/province [415] 0 0
Novosibirsk
Country [416] 0 0
Russian Federation
State/province [416] 0 0
Omsk
Country [417] 0 0
Russian Federation
State/province [417] 0 0
Perm
Country [418] 0 0
Russian Federation
State/province [418] 0 0
Pushkin,St-Petersburg
Country [419] 0 0
Russian Federation
State/province [419] 0 0
Ryazan
Country [420] 0 0
Russian Federation
State/province [420] 0 0
S.-Petersburg
Country [421] 0 0
Russian Federation
State/province [421] 0 0
Saint Petersburg
Country [422] 0 0
Russian Federation
State/province [422] 0 0
Saint-Petersburg
Country [423] 0 0
Russian Federation
State/province [423] 0 0
Saratov
Country [424] 0 0
Russian Federation
State/province [424] 0 0
St-Petersburg
Country [425] 0 0
Russian Federation
State/province [425] 0 0
St. Petersburg
Country [426] 0 0
Russian Federation
State/province [426] 0 0
Tyumen
Country [427] 0 0
Russian Federation
State/province [427] 0 0
Volgograd
Country [428] 0 0
Russian Federation
State/province [428] 0 0
Voronezh
Country [429] 0 0
Russian Federation
State/province [429] 0 0
Yaroslavl
Country [430] 0 0
Slovakia
State/province [430] 0 0
Slovak Republic
Country [431] 0 0
Slovakia
State/province [431] 0 0
Slovak republic
Country [432] 0 0
Slovakia
State/province [432] 0 0
Bardejov
Country [433] 0 0
Slovakia
State/province [433] 0 0
Bratislava
Country [434] 0 0
Slovakia
State/province [434] 0 0
Kosice
Country [435] 0 0
Slovakia
State/province [435] 0 0
Lucenec
Country [436] 0 0
Slovakia
State/province [436] 0 0
Piestany
Country [437] 0 0
Slovakia
State/province [437] 0 0
Presov
Country [438] 0 0
Slovakia
State/province [438] 0 0
Trebisov
Country [439] 0 0
Slovakia
State/province [439] 0 0
Trencin
Country [440] 0 0
Slovakia
State/province [440] 0 0
Zilina
Country [441] 0 0
South Africa
State/province [441] 0 0
Gauteng
Country [442] 0 0
South Africa
State/province [442] 0 0
Benoni
Country [443] 0 0
South Africa
State/province [443] 0 0
Boksburg
Country [444] 0 0
South Africa
State/province [444] 0 0
Centurion
Country [445] 0 0
South Africa
State/province [445] 0 0
Johannesburg
Country [446] 0 0
South Africa
State/province [446] 0 0
Western Cape
Country [447] 0 0
South Africa
State/province [447] 0 0
Worcester
Country [448] 0 0
Spain
State/province [448] 0 0
Andalucia
Country [449] 0 0
Spain
State/province [449] 0 0
Asturias
Country [450] 0 0
Spain
State/province [450] 0 0
Barcelona
Country [451] 0 0
Spain
State/province [451] 0 0
Cadiz
Country [452] 0 0
Spain
State/province [452] 0 0
Catalunya
Country [453] 0 0
Spain
State/province [453] 0 0
Cataluña
Country [454] 0 0
Spain
State/province [454] 0 0
Comunidad Valenciana
Country [455] 0 0
Spain
State/province [455] 0 0
Galicia
Country [456] 0 0
Spain
State/province [456] 0 0
Madrid
Country [457] 0 0
Sweden
State/province [457] 0 0
Falun
Country [458] 0 0
Sweden
State/province [458] 0 0
Göteborg
Country [459] 0 0
Sweden
State/province [459] 0 0
Karlstad
Country [460] 0 0
Sweden
State/province [460] 0 0
Linkoping
Country [461] 0 0
Sweden
State/province [461] 0 0
Lund
Country [462] 0 0
Sweden
State/province [462] 0 0
Malmo
Country [463] 0 0
Sweden
State/province [463] 0 0
Malmö
Country [464] 0 0
Sweden
State/province [464] 0 0
Mölndal
Country [465] 0 0
Sweden
State/province [465] 0 0
Nässjö
Country [466] 0 0
Sweden
State/province [466] 0 0
Skelleftea
Country [467] 0 0
Sweden
State/province [467] 0 0
Stockholm
Country [468] 0 0
Sweden
State/province [468] 0 0
Sundsvall
Country [469] 0 0
Sweden
State/province [469] 0 0
Umeå
Country [470] 0 0
Sweden
State/province [470] 0 0
Uppsala
Country [471] 0 0
Sweden
State/province [471] 0 0
Västerås
Country [472] 0 0
Sweden
State/province [472] 0 0
Örebro
Country [473] 0 0
Switzerland
State/province [473] 0 0
Basel
Country [474] 0 0
Switzerland
State/province [474] 0 0
Bellinzona
Country [475] 0 0
Switzerland
State/province [475] 0 0
Bern
Country [476] 0 0
Switzerland
State/province [476] 0 0
Biel
Country [477] 0 0
Switzerland
State/province [477] 0 0
Bruderholz
Country [478] 0 0
Switzerland
State/province [478] 0 0
Lugano
Country [479] 0 0
Switzerland
State/province [479] 0 0
Olten
Country [480] 0 0
Switzerland
State/province [480] 0 0
Winterthur
Country [481] 0 0
Switzerland
State/province [481] 0 0
Zuerich
Country [482] 0 0
Taiwan
State/province [482] 0 0
Tainan
Country [483] 0 0
Taiwan
State/province [483] 0 0
Taiwan ROC
Country [484] 0 0
Taiwan
State/province [484] 0 0
Kaohsiung
Country [485] 0 0
Taiwan
State/province [485] 0 0
Lin-Kou
Country [486] 0 0
Taiwan
State/province [486] 0 0
Niaosong Township
Country [487] 0 0
Taiwan
State/province [487] 0 0
Taichung
Country [488] 0 0
Taiwan
State/province [488] 0 0
Taipei
Country [489] 0 0
Thailand
State/province [489] 0 0
Bangkok
Country [490] 0 0
Thailand
State/province [490] 0 0
Chiang Mai
Country [491] 0 0
Turkey
State/province [491] 0 0
Ankara
Country [492] 0 0
Turkey
State/province [492] 0 0
Aydin
Country [493] 0 0
Turkey
State/province [493] 0 0
Balcova / Izmir
Country [494] 0 0
Turkey
State/province [494] 0 0
Etlik / Ankara
Country [495] 0 0
Turkey
State/province [495] 0 0
Fatih / Istanbul
Country [496] 0 0
Turkey
State/province [496] 0 0
Istanbul
Country [497] 0 0
Turkey
State/province [497] 0 0
Izmir
Country [498] 0 0
Turkey
State/province [498] 0 0
Kinikli / Denizli
Country [499] 0 0
Turkey
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Kocaeli
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Manchester
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Distrito Capital
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Estado Zulia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study will evaluate the efficacy and safety of both aliskiren monotherapy and
aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity
and mortality in patients with chronic heart failure (NYHA Class II - IV.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00853658
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00853658