A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)(Completed)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00847197
First received: February 18, 2009
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.


Condition Intervention Phase
Dyslipidemia
Drug: MK1903
Drug: Comparator: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Triglycerides (mg/dL) [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 191
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK1903
Drug: MK1903
Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Placebo Comparator: 2
Placebo to MK1903
Drug: Comparator: Placebo
Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is not on a statin or other lipid-modifying therapy
  • Low or moderate risk participant
  • Male participants, and female participants not of reproductive potential

Exclusion Criteria:

  • Female participant of reproductive potential
  • Participant is pregnant, breastfeeding, or expecting to conceive during the study
  • Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer)
  • Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse
  • Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study
  • Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week
  • Participant is currently experiencing menopausal hot flashes
  • Participant currently engages in vigorous exercise or an aggressive diet regimen
  • Participant is at high risk for heart conditions
  • Participant has Type 1 or Type 2 diabetes mellitus
  • Participant has poorly controlled cardiac arrhythmias
  • Participant has a history of stroke or other hemorrhage
  • Participant has poorly controlled high blood pressure
  • Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids
  • Participant has a disease of the kidney or liver
  • Participant has an ulcer within 3 months of screening
  • Participant is Human Immunodeficiency Virus (HIV) positive
  • Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy
  • Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening
  • Participant has taken an anti-obesity medication within 3 months of screening
  • Participant is taking coumarins
  • Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed)
  • Participant is taking more than 100 mg aspirin per day
  • Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847197

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

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00847197     History of Changes
Other Study ID Numbers: MK-1903-004, 2009_542
Study First Received: February 18, 2009
Results First Received: August 27, 2010
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014