Phase 3
N=652
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
Coronary Artery Disease (CAD) · Coronary Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00853827 ↗Enrolled (actual)
652
Serious AEs
28.2%
Results posted
May 2014
Primary outcome: Primary: Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment — -0.33; 0.11 percentage of baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Aliskiren (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment |
-0.33; 0.11 | — |
| SECONDARY Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS |
-4.11; -2.07 | — |
| SECONDARY Patients That Demonstrated Evidence of Atheroma Regression |
128; 114 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events, and Death |
76; 97; 228; 227; 1; 6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00853827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.