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

Phase 2
Completed
Conditions
Mixed Hyperlipidemia
Primary Hypercholesterolemia
Interventions
Drug: SCH 900271
Drug: SCH 900271 15mg
Drug: Placebo
Registration Number
NCT00941603
Lead Sponsor
Merck Sharp & Dohme LLC
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 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
619
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SCH 900271 5 mgSCH 900271Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
SCH 900271 2.5 mgSCH 900271Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
SCH 900271 10 mgSCH 900271Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
SCH 900271 15 mgSCH 900271 15mgParticipants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
PlaceboPlaceboParticipants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
SCH 900271 1 mgSCH 900271Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Direct LDL-C at Week 8Baseline 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 Outcome Measures
NameTimeMethod
Change From Baseline in Direct Non-HDL-C at Week 8Baseline 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.

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