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: September 12, 2013
Last verified: September 2013
  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 in the progression of coronary atherosclerosis (defined as change from baseline in percent atheroma volume) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in normalized total atheroma volume as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients that demonstrate evidence of atheroma regression (defined as any reduction in percent atheroma volume from baseline) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Overall safety and tolerability of aliskiren compared to placebo following treatment duration [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]

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

  Show 128 Study Locations
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
Last Updated: September 12, 2013
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:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on April 15, 2014