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

• Status: Completed
• Trial end date: 2017-11-23
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Anacetrapib; Oxazolidinones

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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