Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00652444
First received: March 31, 2008
Last updated: August 1, 2008
Last verified: August 2008

March 31, 2008
August 1, 2008
September 2003
August 2004   (final data collection date for primary outcome measure)
Percentage reduction of LDL-C after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00652444 on ClinicalTrials.gov Archive Site
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Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: ezetimibe
    ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
    Other Names:
    • Zetia®
    • EZETROL®
    • MK0653
  • Drug: simvastatin
    simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
    Other Names:
    • Zocor®
    • MK0733
  • Drug: Placebo (Unspecified)
    Matching ezetimibe placebo
  • Experimental: 1
    Coadministration arm: simvastatin 20mg and ezetimibe 10mg
    Interventions:
    • Drug: ezetimibe
    • Drug: simvastatin
  • Experimental: 2
    Monotherapy arm: simvastatin 20mg and ezetimibe placebo
    Interventions:
    • Drug: simvastatin
    • Drug: Placebo (Unspecified)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Not Provided
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
  • Age of at least 18 years and 75 years or less
  • Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l

Exclusion Criteria:

  • Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
  • Uncontrolled cardiac arrhythmias
  • Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
  • History of unstable or severe peripheral artery disease within 3 months of study entry
  • Uncontrolled hypertension at study entry
  • Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
  • Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function
  • Active or chronic hepatic and hepatobiliary disease
  • Disorders that would limit study evaluation or participation
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00652444
2008_004
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2008

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