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MK0354 Clinical Efficacy and Tolerability Study (0354-004)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00337415
Recruitment Status : Terminated
First Posted : June 16, 2006
Last Update Posted : May 18, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

June 14, 2006
June 16, 2006
May 18, 2015
May 2006
August 2006   (Final data collection date for primary outcome measure)
proprietary information - exploratory (non-confirmatory) trial
Same as current
Complete list of historical versions of study NCT00337415 on ClinicalTrials.gov Archive Site
proprietary information - exploratory (non-confirmatory) trial
Same as current
Not Provided
Not Provided
MK0354 Clinical Efficacy and Tolerability Study (0354-004)
Proprietary Information - Exploratory (Non-Confirmatory) Trial

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).

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: MK0354
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2006
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP