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

Dyslipidemia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847197
• Other study ID #: 1903-004
• Secondary ID: 2009_542
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2009
• Last updated: November 19, 2015
• Start date: June 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)		Baseline and Week 4	No
Primary	Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)		Baseline and Week 4	No
Secondary	Percent Change From Baseline in Triglycerides (mg/dL)		Baseline and 4 Weeks	No