Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

Condition(s) targeted: Primary Hypercholesterolemia; Mixed Dyslipidemia

Intervention: Comparator: simvastatin (Drug); niacin (+) laropiprant (Drug); Comparator: atorvastatin calcium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12

Secondary outcome:

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12

Percent Change From Baseline in Triglycerides at Week 12

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed

dyslipidemia

- Patients will be eligible for the study if their LDL-C values are within protocol

specified range and meet other entry criteria Exclusion Criteria:

- Patient whose LDL-C values are not within protocol specified range

(MedWatch - FDA maintained medical product safety Information)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: July 2007
Last updated: February 20, 2015