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. 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.

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).

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: MK0354 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study Start Date : May 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Primary Outcome Measures :
  1. proprietary information - exploratory (non-confirmatory) trial

Secondary Outcome Measures :
  1. proprietary information - exploratory (non-confirmatory) trial

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337415

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00337415     History of Changes
Other Study ID Numbers: 0354-004
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases