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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847197
First Posted: February 19, 2009
Last Update Posted: December 21, 2015
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
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

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 ]
  • Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL) [ Time Frame: Baseline and Week 4 ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Triglycerides (mg/dL) [ Time Frame: Baseline and 4 Weeks ]

Enrollment: 191
Study Start Date: June 2008
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00847197


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00847197     History of Changes
Other Study ID Numbers: 1903-004
2009_542
First Submitted: February 18, 2009
First Posted: February 19, 2009
Results First Submitted: August 27, 2010
Results First Posted: September 22, 2010
Last Update Posted: December 21, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases