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

NCT00941603 | Completed Phase 2 Results

• 2 other identifiers: P05675MK-8271-004
• Study Type: interventional
• Target: 619
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Direct Non-HDL-C at Week 8

  Baseline and Week 8

Study Arms (6)

SCH 900271 15 mg

EXPERIMENTAL

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

SCH 900271 10 mg

EXPERIMENTAL

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

SCH 900271 5 mg

EXPERIMENTAL

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

SCH 900271 2.5 mg

EXPERIMENTAL

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

SCH 900271 1 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SCH 900271 15mg DRUG

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

SCH 900271 15 mg

SCH 900271 DRUG

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

SCH 900271 10 mg

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: June 29, 2009
• Primary Completion: February 22, 2010
• Study Completion: February 22, 2010
• Last Updated: September 25, 2018
• Results First Posted: April 12, 2016

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share