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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01059682
First received: January 29, 2010
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
 Drug: dalcetrapib
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Nominal change from baseline to study end in coronary percent atheroma volume (PAV) of the target coronary artery assessed by IVUS. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Rate of change from baseline to study end in carotid intima-media thickness (CIMT) using B-mode ultrasound [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nominal changes from baseline to study end in coronary artery score and cumulative coronary stenosis score as assessed by quantitative coronary angiography [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Blood lipids, lipoproteins [ Time Frame: Throughout study, 24 months ] [ Designated as safety issue: No ]
  • Long-term safety profile: AEs [ Time Frame: AEs: throughout study, 24 months ] [ Designated as safety issue: No ]

Enrollment: 936
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalcetrapib
Dalcetrapib 600 mg orally once daily
Placebo Comparator: 2 Drug: Placebo
Placebo orally once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 CETP-inhibitor or -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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059682

  Show 110 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01059682     History of Changes
Other Study ID Numbers: NC22703
Study First Received: January 29, 2010
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013