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

NCT01059682 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 936

Last updated 2020-03-24

Study results available
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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.

Conditions

Interventions

DRUG

Dalcetrapib

Dalcetrapib 600 mg orally once daily

DRUG

Placebo

Placebo orally once daily

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States
  • Canada
  • Germany
  • Poland
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01059682 on ClinicalTrials.gov