Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
2008-006447-40
Query!
Secondary ID [2]
0
0
CSPP100A2366
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AQUARIUS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease (CAD)
0
0
Query!
Coronary Atherosclerosis
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
Baseline, 104 weeks
Query!
Secondary outcome [1]
0
0
Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
Baseline, 104 weeks
Query!
Secondary outcome [2]
0
0
Patients That Demonstrated Evidence of Atheroma Regression
Query!
Assessment method [2]
0
0
Atheroma regression is defined as change from baseline to endpoint in PAV \<0 .
Query!
Timepoint [2]
0
0
Baseline to endpoint (104 weeks)
Query!
Secondary outcome [3]
0
0
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
104 weeks
Query!
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
Query!
Minimum age
35
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
613
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Liverpool
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - New Lambton Heights
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Adelaide
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Clayton
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
0
0
2305 - New Lambton Heights
Query!
Recruitment postcode(s) [4]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3168 - Clayton
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Minnesota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Mexico
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Dakota
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oklahoma
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oregon
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Tennessee
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Texas
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Capital Federal
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Santa Fe
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Buenos Aires
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Buenos aires
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Corrientes
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Aalst
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Anderlecht
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Brussel
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Bruxelles
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Charleroi
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Genk
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Ottignies
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Alberta
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Manitoba
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Quebec
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Creteil
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Le Plessis Robinson
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Pessac Cedex
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Toulouse Cedex
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Coburg
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Essen
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Frankfurt
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Hamburg
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Leipzig
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Ludwigshafen
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Muenchen
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Neuss
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Baranya
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Budapest
Query!
Country [58]
0
0
Hungary
Query!
State/province [58]
0
0
Debrecen
Query!
Country [59]
0
0
Hungary
Query!
State/province [59]
0
0
Szeged
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
AR
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
BG
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
MI
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
MS
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
PR
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
RM
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
SI
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Novara
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Bialystok
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Kraków
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Lódz
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Warszawa
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Andalucia
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Asturias
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Cantabria
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Cataluña
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Galicia
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Madrid
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Pais Vasco
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Barcelona
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
The Cleveland Clinic
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00853827
Query!
Trial related presentations / publications
Puri R, Nissen SE, Menon V, Shao M, Hsu A, Bakris GL, Kastelein JJ, Williams B, Armbrecht J, Brunel P, Kataoka Y, Nicholls SJ. Effects of aliskiren in diabetic and non-diabetic patients with coronary artery disease: Insights from AQUARIUS. Atherosclerosis. 2015 Dec;243(2):553-9. doi: 10.1016/j.atherosclerosis.2015.10.019. Epub 2015 Oct 20. Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Download to PDF