AzTrials
AzTrials

Cardiovascular DiseasePhase 3NCT01059682

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

A Phase 3 study testing Dalcetrapib in people with Cardiovascular Disease, run by Hoffmann-La Roche at 110 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Disease
What is being tested?
Dalcetrapib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
936 participants
Where
110 sitesin 5 countries
Study dates
Jan 2010to Sep 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

110 sites in 5 countries.

110 sites in 5 countries

Canada44 sites

  • Study site

    Brampton, Ontario, L6Z 4N5

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Cambridge, Ontario, N1R 6V6

  • Study site

    Chicoutimi, Quebec, G7H 5H6

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Edmonton, Alberta, T6G1Z1

  • Study site

    Edmonton, Alberta, V6Z 1Y6

  • Study site

    Fleurimont, Quebec, J1H 5N4

  • Study site

    Gatineau, Quebec, J8Y 6S9

  • Study site

    Greenfield Park, Quebec, J4V 2G8

  • Study site

    Halifax, Nova Scotia, B3H 3A7

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Kitchener, Ontario, N2M 5N4

  • Study site

    Lachine, Quebec, H8S 2E4

  • Study site

    Laval, Quebec, H7M 3L9

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Mississauga, Ontario, L5K 2L3

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Montreal, Quebec, H3J 2V5

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    New Westminster, British Columbia, V3L 3W4

  • Study site

    Newmarket, Ontario, L3Y 2R2

  • Study site

    Oshawa, Ontario, L1J 2J9

  • Study site

    Ottawa, Ontario, K1Y 4W7

  • Study site

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

  • Study site

    Saint John, New Brunswick, E2L 4L2

  • Study site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Study site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Study site

    Saint-Lambert, Quebec, J4P 2H4

  • Study site

    Saskatoon, Saskatchewan, S7N 0W8

  • Study site

    Scarborough Village, Ontario, M1E 4B9

  • Study site

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

  • Study site

    Ste. Foy, Quebec, G1V 4G5

  • Study site

    Sudbury, Quebec, P3E 3Y9

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5B 1W8

  • Study site

    Toronto, Ontario, M5G 1L7

  • Study site

    Trois-Rivières, Quebec, G8Z 3R9

  • Study site

    Val-d'Or, Quebec, J9P 3Y1

  • Study site

    Vancouver, British Columbia, V5Z 1L8

  • Study site

    Victoria, British Columbia, V8R 4Z3

Other trials in Canada

United States41 sites

  • Study site

    Ann Arbor, Michigan, 48109-0666

  • Study site

    Atlantis, Florida, 33462

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boulder, Colorado, 80304

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Chicago, Illinois, 60637-1470

  • Study site

    Columbia, Maryland, 21044

  • Study site

    Dallas, Texas, 75216

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Elkhart, Indiana, 46514

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Greeley, Colorado, 80631

  • Study site

    Hartford, Connecticut, 06115

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Houston, Texas, 77030

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Littleton, Colorado, 80120

  • Study site

    Los Angeles, California, 90033

  • Study site

    Los Angeles, California, 90073

  • Study site

    Louisville, Kentucky, 40205

  • Study site

    Miami, Florida, 33137

  • Study site

    Midland, Michigan, 48670

  • Study site

    Muskegon, Michigan, 49444

  • Study site

    New York, New York, 10011

  • Study site

    Oak Ridge, Tennessee, 37830

  • Study site

    Paramus, New Jersey, 07652

  • Study site

    Petoskey, Michigan, 49770

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rochester, New York, 14642

  • Study site

    Salisbury, Maryland, 21804

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Tampa, Florida, 33609

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Torrance, California, 90502

Other trials in United States

Germany12 sites

  • Study site

    Aachen, 52074

  • Study site

    Berlin, 12203

  • Study site

    Darmstadt, 64283

  • Study site

    Essen, 45138

  • Study site

    Hamburg, 20099

  • Study site

    Hamburg, 22527

  • Study site

    Heidelberg, 69120

  • Study site

    Leipzig, 04289

  • Study site

    München, 80336

  • Study site

    München, 81737

  • Study site

    Regensburg, 93053

  • Study site

    Ulm, 89081

Other trials in Germany

Poland10 sites

  • Study site

    Elblag, 82-300

  • Study site

    Gdansk, 80- 952

  • Study site

    Krakow, 31-202

  • Study site

    Krakow, 31-501

  • Study site

    Lublin, 20- 954

  • Study site

    Poznan, 61-848

  • Study site

    Warsaw, 01- 141

  • Study site

    Warsaw, 02-507

  • Study site

    Warsaw, 04-628

  • Study site

    Wroclaw, 50-981

Other trials in Poland

Switzerland3 sites

  • Study site

    Geneva, 1211

  • Study site

    Kreuzlingen, 8280

  • Study site

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Being tested
Dalcetrapib, Placebo
Medical subject headings
Cardiovascular Diseases

What participants receive

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

  • DalcetrapibDrug

    Dalcetrapib 600 mg orally once daily

  • PlaceboDrug

    Placebo orally once daily

Study groups in NCT01059682
Study groupRoleWhat they receive
DalcetrapibExperimentalNot described
Receives: Drug: Dalcetrapib
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

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

    Measured: 24 months

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

    Measured: 24 months

Secondary outcomes (3)

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

    Measured: 24 months

  2. Blood Lipids, Lipoproteins

    Measured: Throughout study, 24 months

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

    Measured: Throughout Study, 24 months

Timeline

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

  1. First posted1 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionSep 2011
  4. Study completionSep 2011

Why it stopped: Termination of the clinical development program by the Sponsor

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
936 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01059682
Sponsor's protocol ID
NC22703
Status last verified
Mar 2020
First submitted
29 Jan 2010
Last updated
24 Mar 2020

Publications

  • 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.

    PubMed 27418594

  • 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.

    PubMed 25583994

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dalcetrapib in people with Cardiovascular Disease, run by Hoffmann-La Roche at 110 sites in 5 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 7 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: stopped early, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in Canada, United States, Germany, Poland, Switzerland. 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?

Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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). The study lists 2 primary outcomes in all. 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 NCT01059682, which also lists 2 linked publications.

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 24 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in