Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
Condition: Primary Hypercholesterolemia; Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V; Lipidoses; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: SCH 900271 15mg; SCH 900271; SCH 900271; SCH 900271; SCH 900271; Placebo
Intervention description: oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks; oral tablets; SCH 900271 10 mg taken once daily for 8 weeks; oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks; oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks; oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 619.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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