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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00941603
First received: July 16, 2009
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 subjects 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 subject population will also be evaluated.


Condition Intervention Phase
Primary Hypercholesterolemia
Mixed Hyperlipidemia
Drug: SCH 900271
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • To determine 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. [ Time Frame: 8 weeks after baseline measurement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of SCH 900271 compared to placebo on the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to 8 weeks of treatment. [ Time Frame: 8 weeks after baseline measurement ] [ Designated as safety issue: No ]

Enrollment: 619
Study Start Date: June 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCH 900271 (15 mg)
SCH 900271 (15 mg)
Drug: SCH 900271
oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks
Experimental: SCH 900271 (10 mg)
SCH 900271 (10 mg)
Drug: SCH 900271
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
Experimental: SCH 900271 (5 mg)
SCH 900271 (5 mg)
Drug: SCH 900271
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
Experimental: SCH 900271 (2.5 mg)
SCH 900271 (2.5 mg)
Drug: SCH 900271
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
Experimental: SCH 900271 (1 mg)
SCH 900271 (1 mg)
Drug: SCH 900271
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
Placebo Comparator: Placebo
Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 TG).
  • Subject must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations.
  • Subject must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent.

Exclusion Criteria:

The subject 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 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/m2.
  • taking NSAIDS (acetaminophen and 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00941603     History of Changes
Other Study ID Numbers: P05675
Study First Received: July 16, 2009
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipidemias
Hypercholesterolemia
Hyperlipidemia, Familial Combined
Hyperlipoproteinemia Type V
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Hypertriglyceridemia

ClinicalTrials.gov processed this record on September 16, 2014