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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: November 24, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Drug: Placebo
Drug: dalcetrapib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 936
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalcetrapib
Dalcetrapib 600 mg orally once daily
Placebo Comparator: 2 Drug: Placebo
Placebo orally once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059682

  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States, 90073
Los Angeles, California, United States, 90033
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
Ridgewood, New Jersey, United States, 07450
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, T6L5X8
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, M5B 1W8
Toronto, Ontario, Canada, M5G 1L7
Toronto, Ontario, Canada, M4N 3M5
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, H3G 1A4
Montreal, Quebec, Canada, H1T 1C8
Montreal, Quebec, Canada, H4J 1C5
Montréal, Quebec, Canada, H3J 2V5
Montréal, Quebec, Canada, H2W 1T8
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
Germany
Aachen, Germany, 52074
Berlin, Germany, 12203
Darmstadt, Germany, 64283
Essen, Germany, 45138
Hamburg, Germany, 22527
Hamburg, Germany, 20099
Heidelberg, Germany, 69120
Leipzig, Germany, 04289
Muenchen, Germany, 80336
München, Germany, 81737
Regensburg, Germany, 93053
Ulm, Germany, 89081
Poland
Elblag, Poland, 82-300
Gdansk, 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, 01- 141
Warszawa, Poland, 04-628
Wroclaw, Poland, 50-981
Switzerland
Geneve, Switzerland, 1211
Kreuzlingen, Switzerland, 8280
Zürich, Switzerland, 8091
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01059682     History of Changes
Other Study ID Numbers: NC22703
Study First Received: January 29, 2010
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Heart Diseases
Vascular Diseases
Dalcetrapib
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014