Status:
COMPLETED
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Primary Hypercholesterolemia
Mixed Hyperlipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 participa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2010
Estimated Enrollment :
619 Patients enrolled
Trial Details
Trial ID
NCT00941603
Start Date
June 29 2009
End Date
February 22 2010
Last Update
September 25 2018
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