Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hyperch… (NCT00941603) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
619 participantsStarted 2009-06-29
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 …