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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Randomized, Double-Blind, Dose-Response Efficacy and Safety Study of SCH 900271 Compared to Placebo in Subjects With Primary Hypercholesterolemia (Familial and Nonfamilial) or Mixed Hyperlipidemia

Conditions
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Primary Hypercholesterolemia, Mixed Hyperlipidemia

Intervention / Treatment
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* Drug: SCH 900271 15mg
* Drug: SCH 900271
* Drug: SCH 900271
* Drug: SCH 900271
* Drug: SCH 900271
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCH 900271 15 mg<br>Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | Drug: SCH 900271 15mg<br>* oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks<br>|
| Experimental: SCH 900271 10 mg<br>Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | Drug: SCH 900271<br>* oral tablets; SCH 900271 10 mg taken once daily for 8 weeks<br>|
| Experimental: SCH 900271 5 mg<br>Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | Drug: SCH 900271<br>* oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks<br>|
| Experimental: SCH 900271 2.5 mg<br>Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | Drug: SCH 900271<br>* oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks<br>|
| Experimental: SCH 900271 1 mg<br>Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | Drug: SCH 900271<br>* oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks<br>|
| Placebo Comparator: Placebo<br>Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Direct LDL-C at 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. | Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Direct Non-HDL-C at 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. | Baseline and Week 8 |