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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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