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

NCT01059682 | Terminated Phase 3 Results

• 1 other identifier: NC22703
• Study Type: interventional
• Target: 936
• Locations: 5 countries
• Sites: 110

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.

  24 months

• Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound

  24 months

Secondary Outcomes (3)

• Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography

  24 months

• Blood Lipids, Lipoproteins

  Throughout study, 24 months

• Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography

  Throughout Study, 24 months

Study Arms (2)

Dalcetrapib

EXPERIMENTAL

Drug: Dalcetrapib

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dalcetrapib DRUG

Dalcetrapib 600 mg orally once daily

Dalcetrapib

Placebo DRUG

Placebo orally once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over the age of 18 years
• Angiographic evidence of coronary artery disease
• Ultrasound evidence of carotid artery disease
• Treated appropriately for dyslipidemia

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (110)

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90073, United States

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Torrance, California, 90502, United States

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Boulder, Colorado, 80304, United States

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Greeley, Colorado, 80631, United States

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Littleton, Colorado, 80120, United States

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Hartford, Connecticut, 06115, United States

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Atlantis, Florida, 33462, United States

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Fort Lauderdale, Florida, 33308, United States

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Fort Lauderdale, Florida, 33316, United States

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Jacksonville, Florida, 32216, United States

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Miami, Florida, 33137, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33609, United States

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Decatur, Georgia, 30033, United States

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Chicago, Illinois, 60637-1470, United States

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Elkhart, Indiana, 46514, United States

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Louisville, Kentucky, 40205, United States

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Columbia, Maryland, 21044, United States

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Salisbury, Maryland, 21804, United States

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Boston, Massachusetts, 02114, United States

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Ann Arbor, Michigan, 48109-0666, United States

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Kalamazoo, Michigan, 49048, United States

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Midland, Michigan, 48670, United States

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Muskegon, Michigan, 49444, United States

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Petoskey, Michigan, 49770, United States

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Duluth, Minnesota, 55805, United States

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Rochester, Minnesota, 55905, United States

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Kansas City, Missouri, 64114, United States

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Paramus, New Jersey, 07652, United States

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New York, New York, 10011, United States

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Rochester, New York, 14642, United States

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Chapel Hill, North Carolina, 27599, United States

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Toledo, Ohio, 43614, United States

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Hershey, Pennsylvania, 17033, United States

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Providence, Rhode Island, 02906, United States

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Germantown, Tennessee, 38138, United States

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Oak Ridge, Tennessee, 37830, United States

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Dallas, Texas, 75216, United States

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Houston, Texas, 77030, United States

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Richmond, Virginia, 23249, United States

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Calgary, Alberta, T2N 2T9, Canada

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Edmonton, Alberta, T5H 3V9, Canada

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Edmonton, Alberta, T6G1Z1, Canada

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Edmonton, Alberta, V6Z 1Y6, Canada

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New Westminster, British Columbia, V3L 3W4, Canada

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Vancouver, British Columbia, V5Z 1L8, Canada

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Victoria, British Columbia, V8R 4Z3, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Brampton, Ontario, L6Z 4N5, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Cambridge, Ontario, N1R 6V6, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Kitchener, Ontario, N2M 5N4, Canada

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London, Ontario, N6A 5A5, Canada

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Mississauga, Ontario, L5K 2L3, Canada

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Newmarket, Ontario, L3Y 2R2, Canada

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Oshawa, Ontario, L1J 2J9, Canada

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Ottawa, Ontario, K1Y 4W7, Canada

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Scarborough Village, Ontario, M1E 4B9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 1L7, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Fleurimont, Quebec, J1H 5N4, Canada

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Gatineau, Quebec, J8Y 6S9, Canada

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Greenfield Park, Quebec, J4V 2G8, Canada

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Lachine, Quebec, H8S 2E4, Canada

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Laval, Quebec, H7M 3L9, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Montreal, Quebec, H3J 2V5, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Saint Georges-de-beauce, Quebec, G5Y 4T8, Canada

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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

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Saint-Lambert, Quebec, J4P 2H4, Canada

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Ste. Foy, Quebec, G1V 4G5, Canada

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Sudbury, Quebec, P3E 3Y9, Canada

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Trois-Rivières, Quebec, G8Z 3R9, Canada

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Val-d'Or, Quebec, J9P 3Y1, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Aachen, 52074, Germany

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Berlin, 12203, Germany

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Darmstadt, 64283, Germany

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Essen, 45138, Germany

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Hamburg, 20099, Germany

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Hamburg, 22527, Germany

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Heidelberg, 69120, Germany

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Leipzig, 04289, Germany

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München, 80336, Germany

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München, 81737, Germany

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Regensburg, 93053, Germany

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Ulm, 89081, Germany

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Elblag, 82-300, Poland

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Gdansk, 80- 952, Poland

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Krakow, 31-202, Poland

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Krakow, 31-501, Poland

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Lublin, 20- 954, Poland

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Poznan, 61-848, Poland

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Warsaw, 01- 141, Poland

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Warsaw, 02-507, Poland

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Warsaw, 04-628, Poland

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Wroclaw, 50-981, Poland

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Geneva, 1211, Switzerland

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Kreuzlingen, 8280, Switzerland

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Zurich, 8091, Switzerland

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Related Publications (2)

• Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boule M, Alem S, Gregoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rheaume E, Dube MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14.

  PMID: 27418594 DERIVED

• Tardif JC, Rheaume E, Lemieux Perreault LP, Gregoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dube MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11.

  PMID: 25583994 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

dalcetrapib

Results Point of Contact

• Title: Ryan Black
• Organization: DalCor Pharmaceuticals

rblack@dalcorpharma.com

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 1, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Locations

CA (44); CH (3); US (41); PL (10); DE (12)