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

Phase 3

Completed

• Conditions: Coronary Artery Disease (CAD); Coronary Atherosclerosis
• Interventions: Drug: Placebo; Drug: Aliskiren

• Registration Number: NCT00853827
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-27
• Study Start: 2009-03
• Study First Posted: 2009-03-02
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2014-01-23
• Results First Submitted QC: 2014-04-07
• Status Verified: 2014-05
• Results First Posted: 2014-05-07
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 613

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	Aliskiren	Aliskiren 300 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment	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 Outcome Measures

Name	Time	Method
Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS	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
Patients That Demonstrated Evidence of Atheroma Regression	Baseline to endpoint (104 weeks)	Atheroma regression is defined as change from baseline to endpoint in PAV \<0 .
Number of Patients With Adverse Events, Serious Adverse Events, and Death	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Madrid, Spain