Clinical trial NCT00847197: A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
timeFrame: Baseline and Week 4
measure: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Percent Change From Baseline in Triglycerides (mg/dL)
timeFrame: Baseline and 4 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: