A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

November 1, 2016 updated by: Hoffmann-La Roche

A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2220

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

  • Australia
    • Queensland
      • Milton, Queensland, Australia, 4064
    • Victoria
      • Geelong, Victoria, Australia, 3220
    • Western Australia
      • Joondalup, Western Australia, Australia, 6027
  • Canada
      • Quebec, Canada, G1J 1Z4
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
      • Kelowna, British Columbia, Canada, V1Y 1T2
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 4B7
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
      • Barrie, Ontario, Canada, L4M 7G1
      • Burlington, Ontario, Canada, L7M 4Y1
      • Cambridge, Ontario, Canada, N1R 7R1
      • London, Ontario, Canada, N6A 5G6
      • Oakville, Ontario, Canada, L6K 3W7
      • Oshawa, Ontario, Canada, L1H 1B9
      • Oshawa, Ontario, Canada, L1J 2K1
      • Sudbury, Ontario, Canada, P3E 2N8
      • Sudbury, Ontario, Canada, P3E 3B8
      • Thunder Bay, Ontario, Canada, P7B 6V4
      • Toronto, Ontario, Canada, M4G 3E8
    • Quebec
      • Granby, Quebec, Canada, J2G 8Z9
      • Greenfield Park, Quebec, Canada, J4V 3G8
      • Lachine, Quebec, Canada, H8S 2E4
      • Longueuil, Quebec, Canada, J4M 2X1
      • Longueuil, Quebec, Canada, J4N 1C2
      • Mirabel, Quebec, Canada, J7J 2K8
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H1T 3Y7
      • Montréal, Quebec, Canada, H3J 2V5
      • Montréal, Quebec, Canada, H2K 4L5
      • Québec, Quebec, Canada, G1V 4M6
      • St-Lambert, Quebec, Canada, J4P 2H4
      • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Val D'Or, Quebec, Canada, J9P 3Y1
  • China
      • Beijing, China, 100050
      • Nanchang, China, 330006
      • Shijiazhuang, China, 050035
  • Czech Republic
      • Benatky nad Jizerou, Czech Republic, 29471
      • Jindrichuv Hradec, Czech Republic, 377 01
      • Ostrava, Czech Republic, 722 00
      • Pardubice, Czech Republic, 530 02
      • Praha 4, Czech Republic, 140 00
      • Slany, Czech Republic, 274 01
      • Trutnov, Czech Republic, 541 01
  • Denmark
      • Ballerup, Denmark, 2750
      • Hvidovre, Denmark, 2650
      • Vejle, Denmark, 7100
      • Århus N, Denmark, 8200
  • France
      • Pessac, France, 33604
  • Hungary
      • Budapest, Hungary, 1133
      • Budapest, Hungary, 1036
      • Debrecen, Hungary, 4025
      • Kisvarda, Hungary, 4600
      • Komarom, Hungary, 2900
      • Nagykanizsa, Hungary, 8800
      • Pecs, Hungary, 7621
      • Urhida, Hungary, 8142
  • Mexico
      • Aguascaliente, Mexico, 20230
      • Aguascalientes, Mexico, 20230
      • Celaya, Mexico, 38000
      • Chihuahua, Mexico, 31217
      • Cuernavaca, Mexico, 62250
      • D. F., Mexico, 14380
      • Durango, Mexico, 34080
      • Guadalajara, Mexico, 44650
      • Guadalajara, Mexico, 44670
      • Guadalajara, Mexico, 44600
      • Mexico City, Mexico, 11650
      • Monterrey, Mexico, 64060
      • Monterrey, Mexico, 64020
      • Pachuca, Mexico, 42086
      • Queretaro, Mexico, 76000
      • San Luis Potosi S.L.P., Mexico, 78240
      • San Luis Potosí, Mexico, 78200
      • San Luís Potosí, Mexico, 78200
      • Tampico, Mexico, 89000
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
      • Amsterdam, Netherlands, 1105 AZ
      • Apeldoorn, Netherlands, 7334 DZ
      • Breda, Netherlands, 4818 CK
      • Delft, Netherlands, 2625 AD
      • Eindhoven, Netherlands, 5611 NJ
      • Eindhoven, Netherlands, 5632 EJ
      • Gouda, Netherlands, 2803 HH
      • Groningen, Netherlands, 9711 SG
      • Heerlen, Netherlands, 6419 PC
      • Hoorn, Netherlands, 1624 NP
      • Leiden, Netherlands, 2300 RC
      • Rotterdam, Netherlands, 3045 PM
      • Rotterdam, Netherlands, 3021 HC
      • Utrecht, Netherlands, 3584 CX
      • Velp, Netherlands, 6883 ES
      • Venlo, Netherlands, 5912 BL
      • Zoetermeer, Netherlands, 2724 EK
  • Poland
      • Bialystok, Poland, 15-879
      • Gdansk, Poland, 80-286
      • Gdynia, Poland, 81-384
      • Katowice, Poland, 40-748
      • Krakow, Poland, 30-069
      • Lodz, Poland, 91-425
      • Lodz, Poland, 90-302
      • Lublin, Poland, 20-044
      • Lublin, Poland, 20-015
      • Lublin, Poland, 20-538
      • Poznan, Poland, 61-655
      • Pulway, Poland, 24-100
      • Ruda Slaska, Poland, 41-709
      • Warsawa, Poland, 01-192
      • Warszawa, Poland, 02-097
  • Spain
      • Almeria, Spain, 04009
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28009
      • Madrid, Spain, 280146
      • Malaga, Spain, 29010
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
      • Cardiff, United Kingdom, CF14 5GJ
      • Glasgow, United Kingdom, G20 0SP
      • Liverpool, United Kingdom, L22 0LG
      • Manchester, United Kingdom, M15 6SX
      • Reading, United Kingdom, RG2 0TG
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
      • Huntsville, Alabama, United States, 35801
    • California
      • Anaheim, California, United States, 92801
      • Fullerton, California, United States, 92835
      • San Diego, California, United States, 92103
      • Santa Ana, California, United States, 92704
      • Santa Rosa, California, United States, 95405
      • Torrance, California, United States, 90509
      • Torrance, California, United States, 90503
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
      • Denver, Colorado, United States, 80218
      • Lonetree, Colorado, United States, 80124
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
      • Hartford, Connecticut, United States, 06102
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Daytona Beach, Florida, United States, 32114
      • Daytona Beach, Florida, United States, 32117
      • Fort Myers, Florida, United States, 33907
      • Jacksonville, Florida, United States, 32216
      • Panama City, Florida, United States, 32401
      • Plantation, Florida, United States, 33317
      • Port Charlotte, Florida, United States, 33952
      • Tallahassee, Florida, United States, 32308
      • Tampa, Florida, United States, 33613
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Covington, Georgia, United States, 30014
      • Cumming, Georgia, United States, 30041
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Aurora, Illinois, United States, 60504
      • Rock Island, Illinois, United States, 61201
      • Winfield, Illinois, United States, 60190
    • Indiana
      • Elkhart, Indiana, United States, 46617
      • Hammond, Indiana, United States, 46320-1942
      • Indianapolis, Indiana, United States, 46237
      • Indianapolis, Indiana, United States, 46250
      • Muncie, Indiana, United States, 47303
      • South Bend, Indiana, United States, 46601
    • Kansas
      • Overland Park, Kansas, United States, 66215
    • Kentucky
      • Louisville, Kentucky, United States, 40205
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
    • Maine
      • Bangor, Maine, United States, 04401
    • Maryland
      • Beltsville, Maryland, United States, 20705
      • Salisbury, Maryland, United States, 21804
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Haverhill, Massachusetts, United States, 01830
      • Hyannis, Massachusetts, United States, 02601
      • North Dartmouth, Massachusetts, United States, 02747
    • Michigan
      • Jackson, Michigan, United States, 49201
      • Kalamazoo, Michigan, United States, 49048
      • Marquette, Michigan, United States, 49855
      • Midland, Michigan, United States, 48670
      • Rochester Hills, Michigan, United States, 48307
      • Saginaw, Michigan, United States, 48602
      • Ypsilanti, Michigan, United States, 48197
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
      • St. Cloud, Minnesota, United States, 56303
    • Missouri
      • Chesterfield, Missouri, United States, 63017
      • Columbia, Missouri, United States, 65201
      • Kansas City, Missouri, United States, 64111
    • Montana
      • Kalispell, Montana, United States, 59901
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
    • New Jersey
      • Camden, New Jersey, United States, 08103
      • Haddon Heights, New Jersey, United States, 08035
      • Mine Hill, New Jersey, United States, 07803
      • Wayne, New Jersey, United States, 07470
      • Westwood, New Jersey, United States, 07675
    • New York
      • Albany, New York, United States, 12211
      • Albany, New York, United States, 12206-1098
      • Bronx, New York, United States, 10461
      • Buffalo, New York, United States, 14215
      • Cortlandt Manor, New York, United States, 10567
      • Poughkeepsi, New York, United States, 12601
      • Saratoga Springs, New York, United States, 12866
      • Smithtown, New York, United States, 11787
      • Syracuse, New York, United States, 13202
      • Troy, New York, United States, 12180
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Durham, North Carolina, United States, 27710
      • Elizabeth City, North Carolina, United States, 27909
      • Hickory, North Carolina, United States, 28602
      • Morehead City, North Carolina, United States, 28557
      • Rocky Mount, North Carolina, United States, 27804
      • Statesville, North Carolina, United States, 28625
      • Wilmington, North Carolina, United States, 28401
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45227
      • Cleveland, Ohio, United States, 44195
      • Mansfield, Ohio, United States, 44827
      • Mentor, Ohio, United States, 44060
      • Thornville, Ohio, United States, 43076
      • Toledo, Ohio, United States, 43623
      • Zanesville, Ohio, United States, 43701
    • Pennsylvania
      • Allentowm, Pennsylvania, United States, 18105
      • Altoona, Pennsylvania, United States, 16602
      • Camp Hill, Pennsylvania, United States, 17011
      • Doylestown, Pennsylvania, United States, 18901
      • Erie, Pennsylvania, United States, 16550
      • Erie, Pennsylvania, United States, 16502
      • Langhorne, Pennsylvania, United States, 19047
      • Lansdale, Pennsylvania, United States, 19446
      • North Wales, Pennsylvania, United States, 19454-2053
      • Philadelphia, Pennsylvania, United States, 19114
      • Philadelphia, Pennsylvania, United States, 19153
      • Pottstown, Pennsylvania, United States, 19464
      • Tipton, Pennsylvania, United States, 16684
      • West Chester, Pennsylvania, United States, 19380
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Greer, South Carolina, United States, 29651
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
    • Texas
      • Dallas, Texas, United States, 75251
      • Humble, Texas, United States, 77338
      • Odessa, Texas, United States, 79761
      • Tyler, Texas, United States, 75701
    • Utah
      • Provo, Utah, United States, 84004
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Danville, Virginia, United States, 24541-4160
      • Lynchburg, Virginia, United States, 24501
      • Manassas, Virginia, United States, 20109
      • Richmond, Virginia, United States, 23249
      • Winchester, Virginia, United States, 22601

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/= 45 years of age
  • Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
  • Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
  • Receiving evidence-based medical and dietary management of dyslipidemia

Exclusion Criteria:

  • Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Concomitant treatment with any other drug raising HDL-C
  • Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)

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
Experimental: Dalcetrapib
Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
Other: Background care
Guidelines-based medical care
Drug: dalcetrapib
600 mg orally daily
Placebo Comparator: Placebo
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
Other: Background care
Guidelines-based medical care
Drug: Placebo
Matching dalcetrapib placebo orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
Time Frame: approximately 4 years
approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: approximately 4 years
approximately 4 years
All cause mortality
Time Frame: approximately 4 years
approximately 4 years
Change in blood lipid and lipoprotein levels
Time Frame: from baseline to 12 months
from baseline to 12 months

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC25608
  • 2011-001891-21 (EudraCT Number)

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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