Skip to main content
OpenTrials
Completed

NCT Number: NCT00853827

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Atherosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo

Aliskiren

Drug

300 mg

Primary outcomes

  1. Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment

    Time frame: Baseline, 104 weeks

    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 outcomes

  1. Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS

    Time frame: Baseline, 104 weeks

    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

  2. Patients That Demonstrated Evidence of Atheroma Regression

    Time frame: Baseline to endpoint (104 weeks)

    Atheroma regression is defined as change from baseline to endpoint in PAV <0 .

  3. Number of Patients With Adverse Events, Serious Adverse Events, and Death

    Time frame: 104 weeks

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • The Cleveland Clinic

Registry information

Official study 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

Acronym: AQUARIUS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 2, 2009
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.