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
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.

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 August 01, 2014