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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00853827
Ethics application status
Date submitted
26/02/2009
Date registered
27/02/2009
Date last updated
20/05/2014

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 - Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Timepoint [1] 0 0
Baseline, 104 weeks
Secondary outcome [1] 0 0
Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS - Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Timepoint [1] 0 0
Baseline, 104 weeks
Secondary outcome [2] 0 0
Patients That Demonstrated Evidence of Atheroma Regression - Atheroma regression is defined as change from baseline to endpoint in PAV <0 .
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 - overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
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District of Columbia
Country [7] 0 0
United States of America
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Florida
Country [8] 0 0
United States of America
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Georgia
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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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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Canada
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Alberta
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Canada
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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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Poland
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Kraków
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Poland
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Lódz
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Poland
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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
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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
The study will assess the change in coronary atherosclerotic disease as determined by
intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to
standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the
pre-hypertensive range.
Trial website
https://clinicaltrials.gov/show/NCT00853827
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
Other publications