A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease

Cardiovascular Disease Clinical Trial

Official title:

A Multi-Center, Double-blind, Randomized, Placebo Controlled, Parallel Group Study of the Effect of Dalcetrapib on Atherosclerotic Disease Progression As Measured by Coronary Intravascular Ultrasound, Carotid B-Mode Ultrasound and Coronary Angiography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01059682
• Other study ID #: NC22703
• Status: Terminated
• Phase: Phase 3
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg orally once a day or placebo. The anticipated time on study treatment will be 24 months. The target sample size is 800-1000 patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 936
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients over the age of 18 years

• Angiographic evidence of coronary artery disease

• Ultrasound evidence of carotid artery disease

• Treated appropriately for dyslipidemia

Exclusion Criteria:

• Previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or CETP-vaccine within the last 3 months before study start

• Previous coronary artery bypass graft surgery (CABG) or probable need for CABG in the next 24 months

• Myocardial infarction in the target coronary artery for IVUS between the initial IVUS examination and randomization

• Patients who have symptomatic congestive heart failure at baseline (New York Heart Association class III or IV)

• Severe anemia

• Uncontrolled hypertension

• Poorly controlled diabetes

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Dalcetrapib
Dalcetrapib 600 mg orally once daily
• Placebo
Placebo orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.		24 months
Primary	Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound		24 months
Secondary	Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography		24 months
Secondary	Blood Lipids, Lipoproteins		Throughout study, 24 months
Secondary	Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography		Throughout Study, 24 months