MK0354 Clinical Efficacy and Tolerability Study (0354-004)

NCT00337415 | Terminated Phase 2

• 1 other identifier: 0354-004
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• proprietary information - exploratory (non-confirmatory) trial

Secondary Outcomes (1)

• proprietary information - exploratory (non-confirmatory) trial

Interventions

MK0354 DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Dyslipidemias

Interventions

3-(1H-tetrazol-5-yl)-1,4,5,6-tetrahydrocyclopentapyrazole

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 16, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 18, 2015

Record last verified: 2015-05