Status:
COMPLETED
A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT00847197
Start Date
June 1 2008
End Date
September 1 2009
Last Update
December 21 2015
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