MK0354 Clinical Efficacy and Tolerability Study (0354-004)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00337415
First received: June 14, 2006
Last updated: October 8, 2014
Last verified: October 2014

June 14, 2006
October 8, 2014
May 2006
November 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dyslipidemia
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.
 
Terminated
65
November 2006
November 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00337415
0354-004
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

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