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NCT00090298 Clinical Trial

Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)

Hypercholesterolemia Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00090298
Other study ID # 0653A-058
Secondary ID 2004_001
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2004
Est. completion date December 2004

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.

Description:

The duration of treatment is 6 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 2815
Est. completion date December 2004
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility Men and women aged 18 to 69 years, with elevated cholesterol levels may be eligible to participate in a research study to assess the efficacy and safety of two marketed drugs.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653A, ezetimibe (+) simvastatin

• Comparator: Rosuvastatin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Catapano AL, Davidson MH, Ballantyne CM, Brady WE, Gazzara RA, Tomassini JE, Tershakovec AM. Lipid-altering efficacy of the ezetimibe/simvastatin single tablet versus rosuvastatin in hypercholesterolemic patients. Curr Med Res Opin. 2006 Oct;22(10):2041-53. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary LDL-C lowering efficacy after 6 weeks.
Secondary Safety;changes in TC, non-HDL-C, TG, HDL-C, Apo B, LDL-C/HCL-C ratio.
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