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

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: MK1903

• Registration Number: NCT00847197
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-08-27
• Results First Submitted QC: 2010-08-27
• Results First Posted: 2010-09-22
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MK1903	MK1903

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)	Baseline and Week 4
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)	Baseline and Week 4

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Triglycerides (mg/dL)	Baseline and 4 Weeks