Clinical Trial: Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Lipid-Lowering Therapy in Adult Patie

Brief Summary: This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a greater extent than treatment with placebo.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Percent change from Baseline in Low-density Lipoprotein-Cholesterol (LDL-C) using beta-quantification method [ Time Frame: Baseline and Week 12 ]
  • Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN) [ Time Frame: 12 weeks ]
  • Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms [ Time Frame: 12 weeks ]
  • Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN) [ Time Frame: 12 weeks ]
  • Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause [ Time Frame: 12 weeks ]
  • Number of Participants with Significant Increase in Blood Pressure [ Time Frame: 12 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) [ Time Frame: Baseline and Week 12 ]
  • Percent Change from Baseline in Apolipoprotein A-I (apoA-I) [ Time Frame: Baseline and Week 12 ]


Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: April 24, 2013
Date Started: June 2013
Date Completion:
Last Updated: May 29, 2015
Last Verified: May 2015