Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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.
Summary
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.
Clinical Details
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 12Percent Change From Baseline in Triglycerides at Week 12
Eligibility
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
Locations and Contacts
Additional Information
(MedWatch - FDA maintained medical product safety Information) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: July 2007
Last updated: February 20, 2015
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