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

• Status: Completed
• Trial end date: 2010-02-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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