Phase 2
N=191
A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00847197 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL) — -0.3; -1.5 Percent Change — p=0.926
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MK1903 (Drug); Comparator: Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL) |
-0.3; -1.5 | 0.926 |
| PRIMARY Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL) |
6.0; 0.7 | 0.013 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (mg/dL) |
-13.2; -2.0 | 0.02 sig |
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
Data sourced from ClinicalTrials.gov (NCT00847197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.