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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941603
First Posted: July 17, 2009
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 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.

Condition Intervention Phase
Primary Hypercholesterolemia Mixed Hyperlipidemia Drug: SCH 900271 15mg Drug: SCH 900271 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:
  • Change From Baseline in Direct LDL-C at Week 8 [ Time Frame: Baseline and 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.


Secondary Outcome Measures:
  • Change From Baseline in Direct Non-HDL-C at Week 8 [ Time Frame: Baseline and 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.


Enrollment: 619
Actual Study Start Date: June 29, 2009
Study Completion Date: February 22, 2010
Primary Completion Date: February 22, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: SCH 900271 15mg
oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks
Experimental: 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
Drug: SCH 900271
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
Experimental: 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
Drug: SCH 900271
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
Experimental: 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
Drug: SCH 900271
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
Experimental: 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
Drug: SCH 900271
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
Placebo Comparator: Placebo
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941603


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00941603     History of Changes
Other Study ID Numbers: P05675
MK-8271-004 ( Other Identifier: Merck protocol number )
First Submitted: July 16, 2009
First Posted: July 17, 2009
Results First Submitted: March 14, 2016
Results First Posted: April 12, 2016
Last Update Posted: June 12, 2017
Last Verified: May 2017

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