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Coronary Heart Disease (CHD)Phase 3DEFINENCT00685776

Study to Assess the Tolerability and Efficacy of Anacetrapib in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease (MK-0859-019)

A Phase 3 study testing anacetrapib in people with Coronary Heart Disease (CHD) and CHD Risk-Equivalent Disease, run by Merck Sharp & Dohme LLC.

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 study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the safety and tolerability of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent disease on stable dose regimen of statin with or… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
anacetrapib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,623 participants
Where
No sites listed yet
Study dates
24 Mar 2008to 23 Nov 2017
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Base Study:
  • Patient has Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease and is treated with a statin, with well controlled LDL-C
  • Extension Study:
  • Patient has completed the base study including the reversibility period (i.e. 12 or to up to 24 weeks).
  • Patient is on statin therapy ± lipid-modifying therapy since the end of the base study and planning to continue taking a statin throughout the study

Who cannot join

  • History of heart failure, arrhythmias, heart attack, unstable angina, or stroke within 3 months prior to screening, uncontrolled blood pressure, uncontrolled high cholesterol or liver disease.
  • History of mental instability, drug/alcohol abuse within the past 5 years
  • Pregnant or breast-feeding
  • History of cancer within the last 5 years
  • HIV positive
  • Donated blood products within 8 weeks
  • Currently participating or have participated in a study with an investigational compound within the last 30 days

About this study

Official title: A 76-Week, Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Tolerability and Efficacy of Anacetrapib When Added to Ongoing Therapy With a Statin in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease

This study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the safety and tolerability of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent disease on stable dose regimen of statin with or without other lipid-modifying therapy. The two year extension to this study will further evaluate the long-term safety profile and efficacy of anacetrapib in CHD/CHD-risk equivalent patients who are on ongoing therapy with a statin with or without other lipid-modifying therapy.

Read the detailed description

The 76 week treatment period is followed by a 12 week reversibility phase which can be extended by up to another 12 weeks in order to allow participants who have completed their week 88 visit to continue in the study until the Extension study is ready to be implemented.

In the optional extension, participants will be assigned to the same treatment arm to which they were assigned in the base study. The total duration of the extension study will be up to 116 weeks; which will include a 2 year treatment period, followed by a 12 week reversal phase. A post-extension study follow-up phone call will be completed 12 weeks after discontinuation or completion of study treatment. Participants previously treated with anacetrapib or placebo will be invited in a 4:1 ratio in an optional extended reversal phase. The total duration of the extended reversal phase will be 1 year.

Participants previously treated with anacetrapib in the DEFINE study will be followed periodically for up to 4 years to determine plasma levels of anacetrapib. Participants will also be invited to participate in a sub-study consisting of one clinic visit to measure anacetrapib levels in the plasma and the subcutaneous adipose tissue.

ACRONYM: DEFINE= Determining the EFficacy and Tolerability of Cholesteryl ester transfer protein (CETP) INhibition with AnacEtrapib

Being tested
anacetrapib, Comparator: placebo
Keywords
CHD/CHD risk-equivalent disease, Coronary Heart Disease (CHD)
Medical subject headings
Coronary Disease

What participants receive

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

  • anacetrapibDrug

    Also called MK0859

    Participants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.

  • Comparator: placeboDrug

    Participants will receive one placebo tablet once daily for 76 weeks.

Study groups in NCT00685776
Study groupRoleWhat they receive
AnacetrapibExperimentalParticipants randomly assigned to anacetrapib in base study will continue same treatment if enrolled in study extension.
Receives: Drug: anacetrapib
PlaceboPlacebo comparatorParticipants randomly assigned to placebo in base study will continue same treatment if enrolled in study extension.
Receives: Drug: Comparator: placebo

What is being measured

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

  1. Change from baseline in Low Density Lipoprotein Cholesterol

    Measured: Baseline and 24 weeks

  2. Number of participants with hepatitis-related adverse experiences

    Measured: Through 88 weeks

  3. Number of participants with Alanine Transaminase consecutive elevations greater than or equal to 3xULN (Upper Limit of Normal)

    Measured: Through 88 weeks

  4. Number of participants with Aspartate Aminotransferase consecutive elevations greater than or equal to 3xULN

    Measured: Through 88 weeks

  5. Number of participants with Creatine Phosphokinase elevations greater than or equal to 10xULN

    Measured: Through 88 weeks

  6. Number of participants with Creatine Phosphokinase elevations greater than or equal 10xULN with muscle symptoms

    Measured: Through 88 weeks

  7. Number of participants with sodium, chloride, or bicarbonate elevations greater than ULN

    Measured: Through 88 weeks

  8. Number of participants with reduction in potassium levels less than LLN (Lower Limit of Normal)

    Measured: Through 88 weeks

  9. Number of participants with myalgia

    Measured: Through 88 weeks

  10. Number of participants with rhabdomyolysis

    Measured: Through 88 weeks

  11. Number of participants with pre-specified adjudicated cardiovascular serious adverse events

    Measured: Through 88 weeks

  12. Number of participants with death from any cause

    Measured: Through 88 weeks

  13. Number of participants with significant increase in Blood Pressure

    Measured: Through 88 weeks

Secondary outcomes (5)

  1. Change from baseline in High Density Lipoprotein Cholesterol

    Measured: Baseline, 24 weeks, and 76 weeks

  2. Change from baseline in non-High Density Lipoprotein Cholesterol

    Measured: Baseline, 24 weeks, and 76 weeks

  3. Change from baseline in Apolipoprotein B

    Measured: Baseline, 24 weeks, and 76 weeks

  4. Change from baseline in Apolipoprotein A-1

    Measured: Baseline, 24 weeks, and 76 weeks

  5. Change from baseline in Low Density Lipoprotein Cholesterol

    Measured: Baseline, 24 weeks, and 76 weeks

Timeline

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

  1. First posted28 May 2008 (estimated)
  2. Study start24 Mar 2008
  3. Primary completion2 Jul 2009
  4. Study completion23 Nov 2017

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
1,623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00685776
Sponsor's protocol ID
0859-019
Other IDs
2007_648
Acronym
DEFINE
Status last verified
Dec 2017
First submitted
23 May 2008
Last updated
11 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Brinton EA, Kher U, Shah S, Cannon CP, Davidson M, Gotto AM, Ashraf TB, McCrary Sisk C, Dansky H, Mitchel Y, Barter P; DEFINE Investigators. Effects of anacetrapib on plasma lipids in specific patient subgroups in the DEFINE (Determining the Efficacy and Tolerability of CETP INhibition with AnacEtrapib) trial. J Clin Lipidol. 2015 Jan-Feb;9(1):65-71. doi: 10.1016/j.jacl.2014.10.005. Epub 2014 Nov 4.

    PubMed 25670362

  • Gotto AM Jr, Kher U, Chatterjee MS, Liu Y, Li XS, Vaidya S, Cannon CP, Brinton EA, Moon JE, Shah S, Dansky HM, Mitchel Y, Barter P; DEFINE Investigators. Lipids, safety parameters, and drug concentrations after an additional 2 years of treatment with anacetrapib in the DEFINE study. J Cardiovasc Pharmacol Ther. 2014 Nov;19(6):543-9. doi: 10.1177/1074248414529621. Epub 2014 Apr 14.

    PubMed 24737712

  • Cannon CP, Shah S, Dansky HM, Davidson M, Brinton EA, Gotto AM, Stepanavage M, Liu SX, Gibbons P, Ashraf TB, Zafarino J, Mitchel Y, Barter P; Determining the Efficacy and Tolerability Investigators. Safety of anacetrapib in patients with or at high risk for coronary heart disease. N Engl J Med. 2010 Dec 16;363(25):2406-15. doi: 10.1056/NEJMoa1009744. Epub 2010 Nov 17.

    PubMed 21082868

  • Cannon CP, Dansky HM, Davidson M, Gotto AM Jr, Brinton EA, Gould AL, Stepanavage M, Liu SX, Shah S, Rubino J, Gibbons P, Hermanowski-Vosatka A, Binkowitz B, Mitchel Y, Barter P; DEFINE investigators. Design of the DEFINE trial: determining the EFficacy and tolerability of CETP INhibition with AnacEtrapib. Am Heart J. 2009 Oct;158(4):513-519.e3. doi: 10.1016/j.ahj.2009.07.028.

    PubMed 19781408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing anacetrapib in people with Coronary Heart Disease (CHD) and CHD Risk-Equivalent Disease, run by Merck Sharp & Dohme LLC.

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 5 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: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Change from baseline in Low Density Lipoprotein Cholesterol (time frame: Baseline and 24 weeks). The study lists 13 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 NCT00685776, which also lists 4 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 11 Dec 2017.

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