Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)

Phase 3

Terminated

• Conditions: Dyslipidemia
• Interventions: Drug: ERN/LRPT; Drug: placebo

• Registration Number: NCT01414166
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-11
• Study Start: 2011-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2013-11-21
• Results First Submitted QC: 2014-01-30
• Results First Posted: 2014-03-14
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERN/LRPT group	ERN/LRPT	All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT for 16 weeks.
Placebo group	placebo	All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive placebo for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16	Baseline and Weeks 12 to 16	The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16	Baseline and Week 16	The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.
Percent Change From Baseline in Triglycerides (TG) at Week 16	Baseline and Week 16	The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16	Baseline and Week 16	The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.
Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16	Baseline and Week 16	The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.
Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16	Baseline and Week 16	The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.
Percent Change From Baseline in HDL-C at Week 16	Baseline and Week 16	The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.
Percent Change From Baseline in Non-HDL-C at Week 16	Baseline and Week 16	The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16	Baseline and Week 16	The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.