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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Dyslipidemia

Treatments

Drug: MK1903

Drug: Comparator: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00847197

2009_542

1903-004

Details and patient eligibility

About

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.

Enrollment

191 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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