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

Primary Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941603
• Other study ID #: P05675
• Secondary ID: MK-8271-004
• Status: Completed
• Phase: Phase 2
• Start date: June 29, 2009
• Est. completion date: February 22, 2010

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: February 22, 2010
• Est. primary completion date: February 22, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Hyperlipoproteinemias
• Mixed Hyperlipidemia
• Primary Hypercholesterolemia

Intervention

Drug:
• SCH 900271 15mg
oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks
• SCH 900271
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
• SCH 900271
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
• SCH 900271
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
• SCH 900271
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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