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

NCT ID: NCT00536510

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 646 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-03-31

Brief Summary

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

Conditions

Hypercholesterolemia; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

laropiprant/niacin (MK0524A)

Group Type: EXPERIMENTAL

laropiprant/niacin (MK0524A)

Intervention Type: DRUG

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

2

placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

MK0524A

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Kush D, Kim HS, Hu DY, 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 May-Jun;3(3):179-86. doi: 10.1016/j.jacl.2009.04.048. Epub 2009 May 3.

Reference Type: RESULT

PMID: 21291812 (View on PubMed)

Other Identifiers

2007_621

Identifier Type: -

Identifier Source: secondary_id

0524A-048

Identifier Type: -

Identifier Source: org_study_id