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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Hoffmann-La Roche

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 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
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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

Placebo Comparator: Placebo Drug: Placebo
Placebo orally once daily

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01059682

  Hide Study Locations
United States, California
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90073
Torrance, California, United States, 90502
United States, Colorado
Boulder, Colorado, United States, 80304
Greeley, Colorado, United States, 80631
Littleton, Colorado, United States, 80120
United States, Connecticut
Hartford, Connecticut, United States, 06115
United States, Florida
Atlantis, Florida, United States, 33462
Ft. Lauderdale, Florida, United States, 33308
Ft. 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
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Illinois
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Elkhart, Indiana, United States, 46514
United States, Kentucky
Louisville, Kentucky, United States, 40205
United States, Maryland
Columbia, Maryland, United States, 21044
Salisbury, Maryland, United States, 21804
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, 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
United States, Minnesota
Duluth, Minnesota, United States, 55805
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City, Missouri, United States, 64114
United States, New Jersey
Paramus, New Jersey, United States, 07652
United States, New York
New York, New York, United States, 10011
Rochester, New York, United States, 14642
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, Tennessee
Germantown, Tennessee, United States, 38138
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Dallas, Texas, United States, 75216
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23249
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Edmonton, Alberta, Canada, T5H 3V9
Edmonton, Alberta, Canada, T6G1Z1
Edmonton, Alberta, Canada, V6Z 1Y6
Canada, British Columbia
New Westminster, British Columbia, Canada, V3L 3W4
Vancouver, British Columbia, Canada, V5Z 1L8
Victoria, British Columbia, Canada, V8R 4Z3
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, 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, M5B 1W8
Toronto, Ontario, Canada, M5G 1L7
Canada, 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, H1T 1C8
Montreal, Quebec, Canada, H3G 1A4
Montreal, Quebec, Canada, H4J 1C5
Montréal, Quebec, Canada, H2W 1T8
Montréal, Quebec, Canada, H3J 2V5
St-Charles-Borromée, Quebec, Canada, J6E 6J2
St-jerome, Quebec, Canada, J7Z 5T3
St-Lambert, Quebec, Canada, J4P 2H4
St. Georges-de-beauce, Quebec, Canada, G5Y 4T8
Ste. Foy, Quebec, Canada, G1V 4G5
Sudbury, Quebec, Canada, P3E 3Y9
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Val D'or, Quebec, Canada, J9P 3Y1
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
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
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, 01- 141
Warszawa, Poland, 02-507
Warszawa, Poland, 04-628
Wroclaw, Poland, 50-981
Geneve, Switzerland, 1211
Kreuzlingen, Switzerland, 8280
Zürich, Switzerland, 8091
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche