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

Phase 3

Completed

• Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemia
• Interventions: Drug: niacin (+) laropiprant

• Registration Number: NCT00479388
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-28
• Study Start: 2007-07
• Primary Completion: 2008-07
• Study Completion: 2008-10
• Results First Submitted: 2009-06-09
• Results First Submitted QC: 2009-06-09
• Results First Posted: 2009-07-31
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1216

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	niacin (+) laropiprant	One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12	Baseline and 12 Weeks

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12	Baseline and 12 Weeks
Percent Change From Baseline in Triglycerides at Week 12	Baseline and 12 Weeks