MK0354 Clinical Efficacy and Tolerability Study (0354-004)

Dyslipidemia Clinical Trial

Official title:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00337415
• Other study ID #: 0354-004
• Status: Terminated
• Phase: Phase 2
• First received: June 14, 2006
• Last updated: May 15, 2015
• Start date: May 2006
• Est. completion date: August 2006

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• MK0354

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proprietary information - exploratory (non-confirmatory) trial
Secondary	proprietary information - exploratory (non-confirmatory) trial