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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings