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

NCT ID: NCT00941603

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 619 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-29
• Study Completion Date: 2010-02-22

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.

Conditions

Primary Hypercholesterolemia; Mixed Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SCH 900271 15 mg

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

Group Type: EXPERIMENTAL

SCH 900271 15mg

Intervention Type: DRUG

oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks

SCH 900271 10 mg

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

Group Type: EXPERIMENTAL

SCH 900271

Intervention Type: DRUG

oral tablets; SCH 900271 10 mg taken once daily for 8 weeks

SCH 900271 5 mg

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

Group Type: EXPERIMENTAL

SCH 900271

Intervention Type: DRUG

oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks

SCH 900271 2.5 mg

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

Group Type: EXPERIMENTAL

SCH 900271

Intervention Type: DRUG

oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks

SCH 900271 1 mg

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

Group Type: EXPERIMENTAL

SCH 900271

Intervention Type: DRUG

oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

SCH 900271 15mg

oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks

Intervention Type: DRUG

SCH 900271

oral tablets; SCH 900271 10 mg taken once daily for 8 weeks

Intervention Type: DRUG

SCH 900271

oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks

Intervention Type: DRUG

SCH 900271

oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks

Intervention Type: DRUG

SCH 900271

oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-8271-004

Identifier Type: OTHER

Identifier Source: secondary_id

P05675

Identifier Type: -

Identifier Source: org_study_id