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

NCT00536510 | Completed Phase 3 Results

• 2 other identifiers: 0524A-0482007_621
• Study Type: interventional
• Target: 646
• Locations: 0 countries
• Sites: N/A

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

Keywords

High Cholesterol; Excess lipids

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

laropiprant/niacin (MK0524A)

Drug: laropiprant/niacin (MK0524A)

2

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

Interventions

laropiprant/niacin (MK0524A) 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

Also known as: MK0524A

1

Comparator: placebo 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.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21291812 RESULT

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias

Interventions

MK-0524; Niacin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 27, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 2, 2015
• Results First Posted: May 13, 2009

Record last verified: 2015-09