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A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092651
First received: September 23, 2004
Last updated: November 13, 2014
Last verified: November 2014

September 23, 2004
November 13, 2014
September 2002
June 2003   (final data collection date for primary outcome measure)
Plasma LDL-C
Not Provided
Complete list of historical versions of study NCT00092651 on ClinicalTrials.gov Archive Site
Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.
Not Provided
Not Provided
Not Provided
 
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

The duration of treatment is 4 months.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: MK0653A, ezetimibe (+) simvastatin
  • Drug: Comparators: simvastatin and ezetimibe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1398
June 2003
June 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • High cholesterol

Exclusion Criteria:

  • Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00092651
0653A-038, 2004_048
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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