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Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)

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: Dyslipidemia

Intervention: niacin (+) laropiprant (Drug); placebo (unspecified) (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Merck Sharp & Dohme Corp.

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

Summary

The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, 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 Dyslipidemic Patients Deemed Appropriate for Further Lipid Modification.

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

Primary outcome: Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks.

Secondary outcome: Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients 18 years of age or older and on a stable dose of lipid therapy

Exclusion Criteria:

- Patients lipid level is outside the recommended range

- Patients that are HIV positive

Locations and Contacts

Additional Information

MedWatch - FDA maintained medical product safety Information

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

Starting date: September 2008
Last updated: April 8, 2015

Page last updated: August 23, 2015

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