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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Mixed Hyperlipidemia; Primary Hypercholesterolemia

Treatments: Drug: SCH 900271; Drug: Placebo; Drug: SCH 900271 15mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941603

MK-8271-004 (Other Identifier)

P05675

Details and patient eligibility

About

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.

Enrollment: 619 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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619 participants in 6 patient groups, including a placebo group

SCH 900271 15 mg

Experimental group

Description:

Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Treatment:

Drug: SCH 900271 15mg

SCH 900271 10 mg

Experimental group

Description:

Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Treatment:

Drug: SCH 900271

Drug: SCH 900271

Drug: SCH 900271

Drug: SCH 900271

SCH 900271 5 mg

Experimental group

Description:

Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Treatment:

Drug: SCH 900271

Drug: SCH 900271

Drug: SCH 900271

Drug: SCH 900271

SCH 900271 2.5 mg

Experimental group

Description:

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

Treatment:

Drug: SCH 900271

Drug: SCH 900271

Drug: SCH 900271

Drug: SCH 900271

SCH 900271 1 mg

Experimental group

Description:

Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Treatment:

Drug: SCH 900271

Drug: SCH 900271

Drug: SCH 900271

Drug: SCH 900271

Placebo

Placebo Comparator group

Description:

Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks

Treatment:

Drug: Placebo