Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients (AQUARIUS)

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00853827
First received: February 26, 2009
Last updated: May 20, 2014
Last verified: May 2014
Results First Received: January 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease (CAD)
Coronary Atherosclerosis
Interventions: Drug: Placebo
Drug: Aliskiren

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aliskiren Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
Placebo Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg

Participant Flow for 2 periods

Period 1:   Single Blind Period (1 Week)
    Aliskiren     Placebo  
STARTED     652 [1]   0 [2]
COMPLETED     613 [3]   0  
NOT COMPLETED     39     0  
unknown                 4                 0  
Adverse Event                 9                 0  
Abnormal laboratory value                 3                 0  
Abnormal test procedure result                 1                 0  
Withdrawal by Subject                 9                 0  
Lost to Follow-up                 1                 0  
Protocol Violation                 12                 0  
[1] Enrolled patients in single blind
[2] This arm was only used in double blind period
[3] Completed patients in single blind period

Period 2:   Double Blind Period (103 Weeks)
    Aliskiren     Placebo  
STARTED     305 [1]   308  
Modified Full Analysis Set (mFAS)     225     233  
COMPLETED     201     199  
NOT COMPLETED     104     109  
Adverse Event                 25                 14  
Abnormal laboratory values                 0                 3  
Lack of Efficacy                 1                 0  
Patient’s no longer requires study drug                 3                 1  
Protocol Violation                 2                 1  
Withdrawal by Subject                 19                 18  
Lost to Follow-up                 8                 10  
Administrative problems                 45                 56  
Death                 1                 6  
[1] "Started" indicates number of patients in randomized set, full analysis set (FAS) and safety set.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized - All patients who received a randomization number, regardless of whether or not the patient received the trial medication

Reporting Groups
  Description
Aliskiren Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
Placebo Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
Total Total of all reporting groups

Baseline Measures
    Aliskiren     Placebo     Total  
Number of Participants  
[units: participants]
  305     308     613  
Age  
[units: years]
Mean ± Standard Deviation
  60.2  ± 9.35     59.2  ± 8.32     59.7  ± 8.86  
Gender  
[units: participants]
     
Female     77     69     146  
Male     228     239     467  



  Outcome Measures
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1.  Primary:   Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment   [ Time Frame: Baseline, 104 weeks ]

2.  Secondary:   Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS   [ Time Frame: Baseline, 104 weeks ]

3.  Secondary:   Patients That Demonstrated Evidence of Atheroma Regression   [ Time Frame: Baseline to endpoint (104 weeks) ]

4.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events, and Death   [ Time Frame: 104 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00853827     History of Changes
Other Study ID Numbers: CSPP100A2366, 2008-006447-40
Study First Received: February 26, 2009
Results First Received: January 23, 2014
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: Human Research Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Research Ethics Medical Committee
Italy: National Institute of Health
Poland: Ministry of Health
Spain: Spanish Agency of Medicines