Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)
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|ClinicalTrials.gov Identifier: NCT01841684|
Recruitment Status : Terminated
First Posted : April 26, 2013
Last Update Posted : June 1, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipoproteinemia Type II Homozygous Familial Hypercholesterolemia||Drug: Anacetrapib Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Patients With Homozygous Familial Hypercholesterolemia (HoFH)|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Participants receive anacetrapib 100 mg orally once daily for 12 weeks.
100 mg tablet orally, once daily for 12 weeks
Other Name: MK-0859
Placebo Comparator: Placebo
Participants receive placebo orally once daily for 12 weeks.
Placebo for anacetrapib orally, once daily for 12 weeks
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
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