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

March 20, 2020 updated by: Hoffmann-La Roche

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 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

936

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T5H 3V9
      • Edmonton, Alberta, Canada, T6G1Z1
      • Edmonton, Alberta, Canada, V6Z 1Y6
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
      • Vancouver, British Columbia, Canada, V5Z 1L8
      • Victoria, British Columbia, Canada, V8R 4Z3
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • Brampton, Ontario, Canada, L6Z 4N5
      • Burlington, Ontario, Canada, L7M 4Y1
      • Cambridge, Ontario, Canada, N1R 6V6
      • Hamilton, Ontario, Canada, L8L 2X2
      • Kitchener, Ontario, Canada, N2M 5N4
      • London, Ontario, Canada, N6A 5A5
      • Mississauga, Ontario, Canada, L5K 2L3
      • Newmarket, Ontario, Canada, L3Y 2R2
      • Oshawa, Ontario, Canada, L1J 2J9
      • Ottawa, Ontario, Canada, K1Y 4W7
      • Scarborough, Ontario, Canada, M1E 4B9
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 1L7
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Fleurimont, Quebec, Canada, J1H 5N4
      • Gatineau, Quebec, Canada, J8Y 6S9
      • Greenfield Park, Quebec, Canada, J4V 2G8
      • Lachine, Quebec, Canada, H8S 2E4
      • Laval, Quebec, Canada, H7M 3L9
      • Montreal, Quebec, Canada, H4J 1C5
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H3G 1A4
      • Montréal, Quebec, Canada, H2W 1T8
      • Montréal, Quebec, Canada, H3J 2V5
      • Saint Georges-de-beauce, Quebec, Canada, G5Y 4T8
      • St-Charles-Borromée, Quebec, Canada, J6E 6J2
      • St-Lambert, Quebec, Canada, J4P 2H4
      • St-jerome, Quebec, Canada, J7Z 5T3
      • Ste. Foy, Quebec, Canada, G1V 4G5
      • Sudbury, Quebec, Canada, P3E 3Y9
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
      • Val D'or, Quebec, Canada, J9P 3Y1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
  • Germany
      • Aachen, Germany, 52074
      • Berlin, Germany, 12203
      • Darmstadt, Germany, 64283
      • Essen, Germany, 45138
      • Hamburg, Germany, 20099
      • Hamburg, Germany, 22527
      • Heidelberg, Germany, 69120
      • Leipzig, Germany, 04289
      • Muenchen, Germany, 80336
      • München, Germany, 81737
      • Regensburg, Germany, 93053
      • Ulm, Germany, 89081
  • Poland
      • Elblag, Poland, 82-300
      • Gdańsk, Poland, 80- 952
      • Krakow, Poland, 31-202
      • Kraków, Poland, 31-501
      • Lublin, Poland, 20- 954
      • Poznan, Poland, 61-848
      • Warszawa, Poland, 02-507
      • Warszawa, Poland, 04-628
      • Warszawa, Poland, 01- 141
      • Wroclaw, Poland, 50-981
  • Switzerland
      • Geneve, Switzerland, 1211
      • Kreuzlingen, Switzerland, 8280
      • Zürich, Switzerland, 8091
  • United States
    • California
      • Los Angeles, California, United States, 90073
      • Los Angeles, California, United States, 90033
      • Torrance, California, United States, 90502
    • Colorado
      • Boulder, Colorado, United States, 80304
      • Greeley, Colorado, United States, 80631
      • Littleton, Colorado, United States, 80120
    • Connecticut
      • Hartford, Connecticut, United States, 06115
    • Florida
      • Atlantis, Florida, United States, 33462
      • Fort Lauderdale, Florida, United States, 33308
      • Fort Lauderdale, Florida, United States, 33316
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33137
      • Sarasota, Florida, United States, 34239
      • Tampa, Florida, United States, 33609
    • Georgia
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
    • Indiana
      • Elkhart, Indiana, United States, 46514
    • Kentucky
      • Louisville, Kentucky, United States, 40205
    • Maryland
      • Columbia, Maryland, United States, 21044
      • Salisbury, Maryland, United States, 21804
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0666
      • Kalamazoo, Michigan, United States, 49048
      • Midland, Michigan, United States, 48670
      • Muskegon, Michigan, United States, 49444
      • Petoskey, Michigan, United States, 49770
    • Minnesota
      • Duluth, Minnesota, United States, 55805
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Kansas City, Missouri, United States, 64114
    • New Jersey
      • Paramus, New Jersey, United States, 07652
    • New York
      • New York, New York, United States, 10011
      • Rochester, New York, United States, 14642
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Ohio
      • Toledo, Ohio, United States, 43614
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Oak Ridge, Tennessee, United States, 37830
    • Texas
      • Dallas, Texas, United States, 75216
      • Houston, Texas, United States, 77030
    • Virginia
      • Richmond, Virginia, United States, 23249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo orally once daily
Experimental: Dalcetrapib
Drug: Dalcetrapib
Dalcetrapib 600 mg orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months
Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography
Time Frame: 24 months
24 months
Blood Lipids, Lipoproteins
Time Frame: Throughout study, 24 months
Throughout study, 24 months
Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography
Time Frame: Throughout Study, 24 months
Throughout Study, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

January 29, 2010

First Posted (Estimate)

February 1, 2010

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC22703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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