Coronary Heart Disease (CHD) Clinical Trial
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.
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
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