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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00853827




Registration number
NCT00853827
Ethics application status
Date submitted
26/02/2009
Date registered
2/03/2009
Date last updated
3/06/2014

Titles & IDs
Public title
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
Scientific title
A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy
Secondary ID [1] 0 0
2008-006447-40
Secondary ID [2] 0 0
CSPP100A2366
Universal Trial Number (UTN)
Trial acronym
AQUARIUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease (CAD) 0 0
Coronary Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

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

Placebo comparator: 1 -

Experimental: 2 - Aliskiren 300 mg


Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: Aliskiren
300 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
Timepoint [1] 0 0
Baseline, 104 weeks
Secondary outcome [1] 0 0
Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS
Timepoint [1] 0 0
Baseline, 104 weeks
Secondary outcome [2] 0 0
Patients That Demonstrated Evidence of Atheroma Regression
Timepoint [2] 0 0
Baseline to endpoint (104 weeks)
Secondary outcome [3] 0 0
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Timepoint [3] 0 0
104 weeks

Eligibility
Key inclusion criteria
* Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP = 125 and = 139mmHg and a msDBP < 90mmHg.
* Patients with or without current treatment for hypertension
* Angiographic evidence of coronary artery disease
* At least 2 qualifying Cardiovascular risk factors at Visit 1
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Baseline IVUS determined unacceptable
* Patients requiring treatment with disallowed study medications
* Patients with clinically significant heart disease
* Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%
* Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:

* Angiotensin converting enzyme inhibitors
* Angiotensin receptor blockers
* aldosterone receptor blockers or a direct renin inhibitor.
* Other conditions may apply

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 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
1/01/2013
Sample size
Target
Accrual to date
Final
613
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [4] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [5] 0 0
Novartis Investigative Site - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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Indiana
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Kentucky
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Argentina
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Capital Federal
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Argentina
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Santa Fe
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Argentina
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Buenos Aires
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Argentina
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Buenos aires
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Argentina
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Corrientes
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Belgium
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Aalst
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Belgium
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Anderlecht
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Genk
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Belgium
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Ottignies
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Alberta
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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France
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Creteil
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France
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Le Plessis Robinson
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France
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Pessac Cedex
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France
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Toulouse Cedex
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Germany
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Coburg
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Ludwigshafen
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Germany
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Muenchen
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Germany
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Neuss
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Hungary
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Baranya
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Italy
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AR
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Italy
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BG
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Italy
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MI
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Italy
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MS
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Italy
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PR
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Italy
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RM
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Italy
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SI
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Italy
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Novara
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Poland
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Bialystok
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Kraków
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Lódz
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Warszawa
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Spain
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Andalucia
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Spain
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Asturias
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Spain
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Cantabria
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Spain
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Cataluña
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Spain
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Galicia
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Spain
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Madrid
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Spain
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Pais Vasco
Country [79] 0 0
Spain
State/province [79] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Cleveland Clinic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00853827