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

Tracking Information

First Received Date ^ICMJE

January 29, 2010

Last Updated Date

March 25, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01059682 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Cardiovascular Disease

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Intervention: Drug: dalcetrapib
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

936

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Germany, Poland, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01059682

Other Study ID Numbers ^ICMJE

NC22703

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

March 2013

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

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