Effect of MK0524A on Cholesterol Levels… | Clinical Trial

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: MK0524A

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.

Primary outcomes

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks

Time frame: 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

Secondary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 27, 2007
Registry last updated: Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed