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

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ClinicalTrials.gov Identifier: NCT01059682
Recruitment Status : Terminated (Termination of the clinical development program by the Sponsor)
First Posted : February 1, 2010
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Dalcetrapib Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 936 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: Dalcetrapib Drug: Dalcetrapib
Dalcetrapib 600 mg orally once daily
Placebo Comparator: Placebo Drug: Placebo
Placebo orally once daily


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Rate of change from baseline to study end in carotid intima-media thickness (CIMT) using B-mode ultrasound [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Blood lipids, lipoproteins [ Time Frame: Throughout study, 24 months ]
  3. Long-term safety profile: Adverse events (AEs) [ Time Frame: AEs: throughout study, 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059682


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