Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)

The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The safety of SCH 900271 in this participant population will also be evaluated.

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Key information

Conditions

Primary Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Mixed Hyperlipidemia Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Exclusion criteria

The participant will be excluded from entry if ANY of the criteria listed below are met:

use of any investigational drug within 30 days of study entry
female of childbearing potential or lactating
postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
homozygous familial hypercholesterolemia
congestive heart failure New York Heart Association (NYHA) Class III or IV
uncontrolled hypertension on or off therapy
cardiac arrhythmia requiring medication
clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
gastrointestinal ulcer within 3 months of study entry
history of coagulopathy
history of gout
known active or chronic hepatic or biliary disease.
known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
body mass index >40 kg/m^2
taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 [COX-2] inhibitors are allowed)
taking more than 100 mg aspirin per day
being treated with corticosteroids (oral, intramuscular, or intravascular)
more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation

Treatment and study plan

SCH 900271 15mg

Drug

oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks

SCH 900271

Drug

oral tablets; SCH 900271 10 mg taken once daily for 8 weeks

Placebo

Drug

oral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.

Primary outcomes

Change From Baseline in Direct LDL-C at Week 8

Time frame: Baseline and Week 8

The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.

Secondary outcomes

Change From Baseline in Direct Non-HDL-C at Week 8

Time frame: Baseline and Week 8

The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-Blind, Dose-Response Efficacy and Safety Study of SCH 900271 Compared to Placebo in Subjects With Primary Hypercholesterolemia (Familial and Nonfamilial) or Mixed Hyperlipidemia

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 17, 2009
Registry last updated: Sep 25, 2018

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