A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Merck Sharp & Dohme LLC0 sites1,173 target enrollmentMarch 1, 2011

ConditionsPrimary Hypercholesterolemia Mixed Dyslipidemia

InterventionsExtended-release niacin/laropiprant (ERN/LRPT)Placebo

Overview

Phase: Phase 3
Intervention: Extended-release niacin/laropiprant (ERN/LRPT)
Conditions: Primary Hypercholesterolemia
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 1173
Primary Endpoint: Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER) niacin/laropiprant [ERN/LRPT (MK-0524A)] when added to the following ongoing lipid-modifying therapy (LMT): simvastatin,

atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC), or any statin co-administered with ezetimibe. The study is based on the hypothesis that ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.

Registry

clinicaltrials.gov

Start Date

March 1, 2011

End Date

February 26, 2013

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has a history of primary hypercholesterolemia or mixed dyslipidemia.
•Must meet one of the risk categories (very high, high or moderate and corresponding LDL-C criteria at Visit
•Has TG levels \<500 mg/dL (\<5.65 mmol/L).
•Has been on a stable dose of one of the following lipid-modifying therapies (LMTs)for at least 6 weeks prior to Visit 1, and agrees to remain on the same type and dose of LMT for the duration of the study:
•Monotherapy: any statin
•Combination Therapy: ezetimibe/simvastatin in the same tablet
•Co-administration Therapy: any statin co-administered with ezetimibe
•Is male or female and ≥18 years of age on day of signing informed consent.
•A female must meet ONE of the following:
•Of reproductive potential and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the study duration.

Exclusion Criteria

Not provided

Arms & Interventions

Extended-release niacin/laropiprant

ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.

Intervention: Extended-release niacin/laropiprant (ERN/LRPT)

Placebo

Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)

Intervention: Placebo

Outcomes

Primary Outcomes

Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)

Time Frame: Baseline and Week 12

Secondary Outcomes

Percent Change From Baseline in Apo A-I at Week 4(Baseline and Week 4)
Percent Change From Baseline in TC:HDL-C at Week 4(Baseline and Week 4)
Percent Change From Baseline in HDL-C at Week 12(Baseline and Week 12)
Percent Change From Baseline in Triglyceride (TG) at Week 12(Baseline and Week 12)
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12(Baseline and Week 12)
Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12(Baseline and Week 12)
Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12(Baseline and Week 12)
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12(Baseline and Week 12)
Percent Change From Baseline in Apo A-I at Week 12(Baseline and Week 12)
Percent Change From Baseline in LDL-C:HDL-C at Week 4(Baseline and Week 4)
Percent Change From Baseline in HDL-C at Week 4(Baseline and Week 4)
Percent Change From Baseline in TG at Week 4(Baseline and Week 4)
Percent Change From Baseline in Apo B at Week 4(Baseline and Week 4)
Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline and Week 12)
Percent Change From Baseline in Non-HDL-C at Week 12(Baseline and Week 12)
Percent Change From Baseline in Lp(a) at Week 4(Baseline and Week 4)
Percent Change From Baseline in TC at Week 4(Baseline and Week 4)
Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment(Baseline and 12 weeks)
Percent Change From Baseline in TC at Week 12(Baseline and Week 12)
Percent Change From Baseline in LDL-C at Week 4(Baseline and Week 4)
Percent Change From Baseline in Non-HDL-C at Week 4(Baseline and Week 4)
Percent Change From Baseline in Apo B:Apo A-I at Week 4(Baseline and Week 4)