CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 613 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Aliskiren 300 mgAI-extracted
Key inclusion· 3
  • ✓Blood pressure in pre-hypertensive range: systolic 125-139 mmHg and diastolic <90 mmHg
  • ✓Angiographic evidence of coronary artery disease
  • ✓At least 2 qualifying cardiovascular risk factors at baseline visit
Key exclusion· 4
  • ✕NYHA Class IV heart failure or left ventricular ejection fraction <25%
  • ✕Concurrent treatment with ≥2 agents from: ACE inhibitors, ARBs, aldosterone receptor blockers, or direct renin inhibitors
  • ✕Baseline IVUS determined unacceptable
  • ✕Clinically significant heart disease (unspecified severity)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00853827
NCT00853827Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Mar 2, 2009·Updated Jun 3, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo and Aliskiren for Coronary Artery Disease (CAD) and Coronary Atherosclerosis. Completed, enrolled 613 participants across 129 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease (CAD), Coronary Atherosclerosis
CountriesArgentina, Australia, Belgium, Canada, France, Germany, Hungary, Italy, Poland, Spain, United States
CollaboratorsThe Cleveland Clinic

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2009
Enrollment StartMar 1, 2009
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.3 years ago

Interventions

Placebodrug

Placebo

Aliskirendrug

300 mg