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: October 20, 2014
Last verified: October 2014

January 29, 2010
October 20, 2014
January 2010
July 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01059682 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
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

This multicenter, double-blind, randomized, placebo-controlled study will evalua te the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lip id 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 A ngiography 2. Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary arte ry disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg oral ly once a day or placebo. The anticipated time on study treatment will be 24 mon ths. The target sample size is 800-1000 patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cardiovascular Disease
  • Drug: Placebo
    Placebo orally once daily
  • Drug: dalcetrapib
    Dalcetrapib 600 mg orally once daily
  • Experimental: 1
    Intervention: Drug: dalcetrapib
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
936
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States,   Switzerland,   Germany,   Poland
 
NCT01059682
NC22703
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP