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Coronary Heart DiseasePhase 3NCT01323153

A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)

A Phase 3 study testing dalcetrapib in people with Coronary Heart Disease, run by Hoffmann-La Roche at 33 sites in 4 countries.

Completed

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

Official record
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Trial summary

This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Coronary Heart 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
300 participants
Where
33 sitesin 4 countries
Study dates
Mar 2011to Mar 2012
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, >/=45 years of age
  • Patients admitted to the hospital for acute coronary syndrome (ACS)
  • Patients receiving guideline-based medical and dietary management of dyslipidemia

Who cannot join

  • Symptomatic congestive heart failure (NYHA Class III or IV)
  • Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Severe anemia
  • Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

Netherlands12 sites

  • Study site

    Amsterdam, 1091 AC

  • Study site

    Arnhem, 6815 AD

  • Study site

    Beverwijk, 1942 LE

  • Study site

    Breda, 4818 CK

  • Study site

    Den Helder, 1782GZ

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Gouda, 2803 HH

  • Study site

    Heerlen, 6419 PC

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Nijmegen, 6532 SZ

  • Study site

    Rotterdam, 3045 PM

  • Study site

    Sneek, 8601 ZK

Other trials in Netherlands

Czechia10 sites

  • Study site

    České Budějovice, 370 87

  • Study site

    Chrudim, 537 25

  • Study site

    Hradec Králové, 500 05

  • Study site

    Jihlava, 586 01

  • Study site

    Jindřichův Hradec, 377 38

  • Study site

    Prague, 100 34

  • Study site

    Semily, 513 31

  • Study site

    Teplice, 415 01

  • Study site

    Zlín, 762 75

  • Study site

    Znojmo, 669 02

Other trials in Czechia

United States6 sites

  • Study site

    Pensacola, Florida, 32501

  • Study site

    Pensacola, Florida, 32504

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Saginaw, Michigan, 48602

  • Study site

    Saint Cloud, Minnesota, 56303

  • Study site

    Syracuse, New York, 13210

Other trials in United States

United Kingdom5 sites

  • Study site

    Edinburgh, EH16 4SA

  • Study site

    Glasgow, G31 2ER

  • Study site

    London, EC1M 6BQ

  • Study site

    Stoke-on-Trent, ST4 6QG

  • Study site

    Swansea, SA6 6NL

Other trials in United Kingdom

About this study

Official title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.

Being tested
dalcetrapib, placebo
Medical subject headings
Coronary Disease

What participants receive

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

  • dalcetrapibDrug

    Oral doses of 600 mg once daily for 20 weeks

  • placeboDrug

    Oral doses of matching placebo to dalcetrapib once daily for 20 weeks

Study groups in NCT01323153
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. Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment

    Measured: 4 weeks

Secondary outcomes (6)

  1. Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971

    Measured: 4 weeks

  2. Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment

    Measured: 20 weeks

  3. Percent Change From Baseline in Blood Lipid Levels

    Measured: 20 weeks

  4. Percent Change From Baseline in Lipoprotein Levels

    Measured: 20 weeks

  5. Percent Change From Baseline in Apolipoprotein Levels

    Measured: 20 weeks

  6. Safety: Incidence of Adverse Events

    Measured: 24 weeks

Timeline

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

  1. First posted25 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2012
  4. Study completionMar 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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01323153
Sponsor's protocol ID
WC25501
Status last verified
Jul 2019
First submitted
24 Mar 2011
Last updated
30 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dalcetrapib in people with Coronary Heart Disease, run by Hoffmann-La Roche at 33 sites in 4 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 3 inclusion and 6 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Netherlands, Czechia, United States, United Kingdom. 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 6 Aug 2018). 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?

Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment (time frame: 4 weeks). 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 NCT01323153.

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 30 Jul 2019.

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