Anacetrapib
DrugParticipants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.
Other names: MK0859
NCT Number: NCT00685776
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 3
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.
Other names: MK0859
Participants will receive one placebo tablet once daily for 76 weeks.
Time frame: Baseline and 24 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Through 88 weeks
Time frame: Baseline, 24 weeks, and 76 weeks
Time frame: Baseline, 24 weeks, and 76 weeks
Time frame: Baseline, 24 weeks, and 76 weeks
Time frame: Baseline, 24 weeks, and 76 weeks
Time frame: Baseline, 24 weeks, and 76 weeks
Merck Sharp & Dohme LLC
Industry
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
Acronym: DEFINE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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