MK0354 Clinical Efficacy and Tolerability Study (0354-004)

NCT ID: NCT00337415

Last Updated: 2015-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2006-08-31

Brief Summary

A Research Study to Evaluate the Effectiveness and Tolerability of MK0354 vs Placebo (an inactive look alike pill) in Lipid (fat) Altering in Patients with dyslipidemia (a disorder of lipids in the blood)

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

MK0354

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient is between 18 and 75 years of age
• You have taken a statin or other lipid modifying therapy in the last 6-8 weeks
• You have lipid lab values outside of the range specified in the protocol

Exclusion Criteria

• Patient is a woman who is pregnant or nursing a child
• Patient is a woman who is taking hormonal birth-control
• You are a woman who is planning to donate eggs during the study
• You plan to give blood during the study or have given within the last 8 weeks
• You are a woman who is having menopausal hot flashes or are taking medications to prevent menopausal hot flashes
• You have a known intolerance to or you are allergic to niacin
• You have any of the following medical conditions:
• Poorly controlled or newly diagnosed diabetes (within the last 3 months)
• Thyroid disease (hypothyroidism or hyperthyroidism)
• A history of stroke, heart attack, coronary bypass surgery, angioplasty, unstable angina or similar heart and artery procedures in the past 3 months
• History of hemorrhagic stroke or other non-traumatic hemorrhage
• Peptic ulcer disease in the last 3 months
• An occurrence of gout within the last year and you are not currently taking allopurinol
• Cancer (except for successfully treated skin cancer)
• HIV positive
• You have a history of drug/alcohol abuse within the last year
• You consume more than 2 drinks of alcohol per day
• You do not have access to a telephone
• You take medications that are not allowed in this study. The study doctor or staff will discuss this with you.
• Patient has participated in a study with an investigational drug within the last 30 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

0354-004

Identifier Type: -

Identifier Source: org_study_id