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AzTrials

Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)Phase 3NCT01516541

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

A Phase 3 study testing Background care and dalcetrapib in people with Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD), run by Hoffmann-La Roche at 241 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
Background care and dalcetrapib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,220 participants
Where
241 sitesin 13 countries
Study dates
Jan 2012to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

241 sites in 13 countries.

241 sites in 13 countries

United States121 sites

  • Study site

    Albany, New York, 12206-1098

  • Study site

    Albany, New York, 12211

  • Study site

    Alexandria, Louisiana, 71301

  • Study site

    Allentowm, Pennsylvania, 18105

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Anaheim, California, 92801

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Aurora, Illinois, 60504

  • Study site

    Bangor, Maine, 04401

  • Study site

    Beltsville, Maryland, 20705

  • Study site

    Birmingham, Alabama, 35294-0007

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Buffalo, New York, 14215

  • Study site

    Camden, New Jersey, 08103

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Cincinnati, Ohio, 45227

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbia, Missouri, 65201

  • Study site

    Cortlandt Manor, New York, 10567

  • Study site

    Covington, Georgia, 30014

  • Study site

    Cumming, Georgia, 30041

  • Study site

    Dallas, Texas, 75251

  • Study site

    Danville, Virginia, 24541-4160

  • Study site

    Daytona Beach, Florida, 32114

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado, 80218

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Elizabeth City, North Carolina, 27909

  • Study site

    Elkhart, Indiana, 46617

  • Study site

    Erie, Pennsylvania, 16502

  • Study site

    Erie, Pennsylvania, 16550

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fort Myers, Florida, 33907

  • Study site

    Fullerton, California, 92835

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Haddon Heights, New Jersey, 08035

  • Study site

    Hammond, Indiana, 46320-1942

  • Study site

    Hartford, Connecticut, 06102

  • Study site

    Haverhill, Massachusetts, 01830

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Humble, Texas, 77338

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Hyannis, Massachusetts, 02601

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Indianapolis, Indiana, 46250

  • Study site

    Jackson, Michigan, 49201

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Kalispell, Montana, 59901

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Langhorne, Pennsylvania, 19047

  • Study site

    Lansdale, Pennsylvania, 19446

  • Study site

    Lonetree, Colorado, 80124

  • Study site

    Louisville, Kentucky, 40205

  • Study site

    Lynchburg, Virginia, 24501

  • Study site

    Manassas, Virginia, 20109

  • Study site

    Mansfield, Ohio, 44827

  • Study site

    Marquette, Michigan, 49855

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Midland, Michigan, 48670

  • Study site

    Mine Hill, New Jersey, 07803

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Muncie, Indiana, 47303

  • Study site

    Nashua, New Hampshire, 03060

  • Study site

    North Dartmouth, Massachusetts, 02747

  • Study site

    North Wales, Pennsylvania, 19454-2053

  • Study site

    Odessa, Texas, 79761

  • Study site

    Overland Park, Kansas, 66215

  • Study site

    Panama City, Florida, 32401

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Philadelphia, Pennsylvania, 19153

  • Study site

    Plantation, Florida, 33317

  • Study site

    Port Charlotte, Florida, 33952

  • Study site

    Pottstown, Pennsylvania, 19464

  • Study site

    Poughkeepsi, New York, 12601

  • Study site

    Provo, Utah, 84004

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Rochester, Minnesota, 55905-0001

  • Study site

    Rochester Hills, Michigan, 48307

  • Study site

    Rock Island, Illinois, 61201

  • Study site

    Rocky Mount, North Carolina, 27804

  • Study site

    Saginaw, Michigan, 48602

  • Study site

    Saint Cloud, Minnesota, 56303

  • Study site

    Salisbury, Maryland, 21804

  • Study site

    San Diego, California, 92103

  • Study site

    Santa Ana, California, 92704

  • Study site

    Santa Rosa, California, 95405

  • Study site

    Saratoga Springs, New York, 12866

  • Study site

    Smithtown, New York, 11787

  • Study site

    South Bend, Indiana, 46601

  • Study site

    Statesville, North Carolina, 28625

  • Study site

    Syracuse, New York, 13202

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Tampa, Florida, 33613

  • Study site

    The Bronx, New York, 10461

  • Study site

    Thornville, Ohio, 43076

  • Study site

    Tipton, Pennsylvania, 16684

  • Study site

    Toledo, Ohio, 43623

  • Study site

    Torrance, California, 90503

  • Study site

    Torrance, California, 90509

  • Study site

    Troy, New York, 12180

  • Study site

    Tyler, Texas, 75701

  • Study site

    Wayne, New Jersey, 07470

  • Study site

    West Chester, Pennsylvania, 19380

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    Westwood, New Jersey, 07675

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winchester, Virginia, 22601

  • Study site

    Winfield, Illinois, 60190

  • Study site

    Ypsilanti, Michigan, 48197

  • Study site

    Zanesville, Ohio, 43701

Other trials in United States

Canada31 sites

  • Study site

    Ajax, Ontario, L1S 7K8

  • Study site

    Barrie, Ontario, L4M 7G1

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Cambridge, Ontario, N1R 7R1

  • Study site

    Coquitlam, British Columbia, V3K 3P4

  • Study site

    Granby, Quebec, J2G 8Z9

  • Study site

    Greater Sudbury, Ontario, P3E 2N8

  • Study site

    Greater Sudbury, Ontario, P3E 3B8

  • Study site

    Greenfield Park, Quebec, J4V 3G8

  • Study site

    Kelowna, British Columbia, V1Y 1T2

  • Study site

    Lachine, Quebec, H8S 2E4

  • Study site

    London, Ontario, N6A 5G6

  • Study site

    Longueuil, Quebec, J4M 2X1

  • Study site

    Longueuil, Quebec, J4N 1C2

  • Study site

    Mirabel, Quebec, J7J 2K8

  • Study site

    Moncton, New Brunswick, E1C 4B7

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H1T 3Y7

  • Study site

    Montreal, Quebec, H2K 4L5

  • Study site

    Montreal, Quebec, H3J 2V5

  • Study site

    Oakville, Ontario, L6K 3W7

  • Study site

    Oshawa, Ontario, L1H 1B9

  • Study site

    Oshawa, Ontario, L1J 2K1

  • Study site

    Québec, Quebec, G1J 1Z4

  • Study site

    Québec, Quebec, G1V 4M6

  • Study site

    Saint-Lambert, Quebec, J4P 2H4

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Toronto, Ontario, M4G 3E8

  • Study site

    Trois-Rivières, Quebec, G8T 7A1

  • Study site

    Val-d'Or, Quebec, J9P 3Y1

  • Study site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Mexico19 sites

  • Study site

    Aguascaliente, 20230

  • Study site

    Aguascalientes, 20230

  • Study site

    Celaya, 38000

  • Study site

    Chihuahua City, 31217

  • Study site

    Cuernavaca, 62250

  • Study site

    D. F., 14380

  • Study site

    Durango, 34080

  • Study site

    Guadalajara, 44600

  • Study site

    Guadalajara, 44650

  • Study site

    Guadalajara, 44670

  • Study site

    Mexico City, 11650

  • Study site

    Monterrey, 64020

  • Study site

    Monterrey, 64060

  • Study site

    Pachuca, 42086

  • Study site

    Querétaro, 76000

  • Study site

    San Luís Potosí, 78200

  • Study site

    San Luis Potosí City, 78200

  • Study site

    San Luis Potosi S.l.p., 78240

  • Study site

    Tampico, 89000

Other trials in Mexico

Netherlands18 sites

  • Study site

    Alkmaar, 1815 JD

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Apeldoorn, 7334 DZ

  • Study site

    Breda, 4818 CK

  • Study site

    Delft, 2625 AD

  • Study site

    Eindhoven, 5611 NJ

  • Study site

    Eindhoven, 5632 EJ

  • Study site

    Gouda, 2803 HH

  • Study site

    Groningen, 9711 SG

  • Study site

    Heerlen, 6419 PC

  • Study site

    Hoorn, 1624 NP

  • Study site

    Leiden, 2300 RC

  • Study site

    Rotterdam, 3021 HC

  • Study site

    Rotterdam, 3045 PM

  • Study site

    Utrecht, 3584 CX

  • Study site

    Velp, 6883 ES

  • Study site

    Venlo, 5912 BL

  • Study site

    Zoetermeer, 2724 EK

Other trials in Netherlands

Poland15 sites

  • Study site

    Bialystok, 15-879

  • Study site

    Gdansk, 80-286

  • Study site

    Gdynia, 81-384

  • Study site

    Katowice, 40-748

  • Study site

    Krakow, 30-069

  • Study site

    Lodz, 90-302

  • Study site

    Lodz, 91-425

  • Study site

    Lublin, 20-015

  • Study site

    Lublin, 20-044

  • Study site

    Lublin, 20-538

  • Study site

    Poznan, 61-655

  • Study site

    Pulway, 24-100

  • Study site

    Ruda Śląska, 41-709

  • Study site

    Warsaw, 01-192

  • Study site

    Warsaw, 02-097

Other trials in Poland

Hungary8 sites

  • Study site

    Budapest, 1036

  • Study site

    Budapest, 1133

  • Study site

    Debrecen, 4025

  • Study site

    Kisvárda, 4600

  • Study site

    Komárom, 2900

  • Study site

    Nagykanizsa, 8800

  • Study site

    Pécs, 7621

  • Study site

    Úrhida, 8142

Other trials in Hungary

Czechia7 sites

  • Study site

    Benátky nad Jizerou, 29471

  • Study site

    Jindřichův Hradec, 377 01

  • Study site

    Ostrava, 722 00

  • Study site

    Pardubice, 530 02

  • Study site

    Prague, 140 00

  • Study site

    Slaný, 274 01

  • Study site

    Trutnov, 541 01

Other trials in Czechia

United Kingdom6 sites

  • Study site

    Birmingham, B15 2SQ

  • Study site

    Cardiff, CF14 5GJ

  • Study site

    Glasgow, G20 0SP

  • Study site

    Liverpool, L22 0LG

  • Study site

    Manchester, M15 6SX

  • Study site

    Reading, RG2 0TG

Other trials in United Kingdom

Spain5 sites

  • Study site

    Almería, Almeria, 04009

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Madrid, Madrid, 28009

  • Study site

    Madrid, Madrid, 280146

  • Study site

    Málaga, Malaga, 29010

Other trials in Spain

Denmark4 sites

  • Study site

    Århus N, 8200

  • Study site

    Ballerup Municipality, 2750

  • Study site

    Hvidovre, 2650

  • Study site

    Vejle, 7100

Other trials in Denmark

Australia3 sites

  • Study site

    Geelong, Victoria, 3220

  • Study site

    Joondalup, Western Australia, 6027

  • Study site

    Milton, Queensland, 4064

Other trials in Australia

China3 sites

  • Study site

    Beijing, 100050

  • Study site

    Nanchang, 330006

  • Study site

    Shijiazhuang, 050035

Other trials in China

France1 site

  • Study site

    Pessac, 33604

Other trials in France

About this study

Official title: 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.

Being tested
Background care, Placebo, dalcetrapib
Medical subject headings
Cardiovascular Diseases, Coronary Disease, Dyslipidemias, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Background careOther

    Guidelines-based medical care

  • PlaceboDrug

    Matching dalcetrapib placebo orally daily

  • dalcetrapibDrug

    600 mg orally daily

Study groups in NCT01516541
Study groupRoleWhat they receive
DalcetrapibExperimentalDalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
Receives: Other: Background care; Drug: dalcetrapib
PlaceboPlacebo comparatorPlacebo orally daily, on a background of contemporary, guidelines-based medical care.
Receives: Other: Background care; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)

    Measured: approximately 4 years

Secondary outcomes (3)

  1. All cause mortality

    Measured: approximately 4 years

  2. Safety: Incidence of adverse events

    Measured: approximately 4 years

  3. Change in blood lipid and lipoprotein levels

    Measured: from baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516541
Sponsor's protocol ID
NC25608
Other IDs
2011-001891-21
Status last verified
Nov 2016
First submitted
13 Jan 2012
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Background care and dalcetrapib in people with Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD), run by Hoffmann-La Roche at 241 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 241 sites in United States, Canada, Mexico, Netherlands, Poland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) (time frame: approximately 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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