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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease (CAD)
Coronary Atherosclerosis
Drug: Placebo
Drug: Aliskiren
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
    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

  • Patients That Demonstrated Evidence of Atheroma Regression [ Time Frame: Baseline to endpoint (104 weeks) ] [ Designated as safety issue: No ]
    Atheroma regression is defined as change from baseline to endpoint in PAV <0 .

  • Number of Patients With Adverse Events, Serious Adverse Events, and Death [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 613
Study Start Date: March 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo
Experimental: 2
Aliskiren 300 mg
Drug: Aliskiren
300 mg

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853827

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Madrid, Spain, 28046
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Madrid, Spain, 28040
Sponsors and Collaborators
Novartis Pharmaceuticals
The Cleveland Clinic
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Novartis:
CAD
coronary artery disease
coronary atherosclerosis
coronary angiography
IVUS
intravascular ultrasound
plasma renin activity
renin angiotensin aldosterone system,
direct renin inhibitors
coronary atheroma

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Arteriosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014