Effect of MK0524A on Cholesterol Levels (0524A-048)

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Lipid-Altering Efficacy and Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536510
• Other study ID #: 0524A-048
• Secondary ID: 2007_621
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2007
• Last updated: September 1, 2015
• Start date: April 2007
• Est. completion date: March 2008

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient is male or female between 18 and 70 years of age

• Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

Exclusion Criteria:

• Patient has a history of not being able to take niacin or niacin-containing products

• Patient consumes more than 2 alcoholic beverages per day

• Patient has poorly controlled Type 1 or Type 2 diabetes mellitus

• Patient engages in vigorous exercise or an aggressive diet regimen

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• laropiprant/niacin (MK0524A)
Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization
• Comparator: placebo
Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Kush D, Kim HS, Hu da Y, Liu J, Sirah W, Sapre A, McCrary Sisk C, Paolini JF, Maccubbin D. Lipid-modifying efficacy of extended release niacin/laropiprant in Asian patients with primary hypercholesterolemia or mixed hyperlipidemia. J Clin Lipidol. 2009 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks	Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100	12 weeks	No
Secondary	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks	Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100	12 weeks	No