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

NCT ID: NCT00847197

Last Updated: 2015-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

MK1903

Group Type EXPERIMENTAL

MK1903

Intervention Type DRUG

Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.

2

Placebo to MK1903

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.

Interventions

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MK1903

Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.

Intervention Type DRUG

Comparator: Placebo

Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Canada Colombia Finland Malaysia Peru Philippines Sweden United States

Other Identifiers

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2009_542

Identifier Type: -

Identifier Source: secondary_id

1903-004

Identifier Type: -

Identifier Source: org_study_id