A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01824238|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 25, 2016
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.
|Condition or disease||Intervention/treatment||Phase|
|Heterozygous Familial Hypercholesterolemia (HeFH)||Drug: Anacetrapib Drug: Placebo for anacetrapib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 12-Week, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Therapies in Japanese Patients With Heterozygous Familial Hypercholesterolemia|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Participants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.
Other Name: MK-0859
Placebo Comparator: Placebo
Participants will receive placebo tablet, orally, once daily for 12 weeks.
Drug: Placebo for anacetrapib
Primary Outcome Measures :
- Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 12 ]
- Percentage of Participants who Experience at Least One Adverse Event (AE) [ 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 Non-HDL-C [ Time Frame: Baseline and Week 12 ]
- Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 12 ]
- Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 12 ]
- Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline and Week 12 ]
No Contacts or Locations Provided