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NCT00651560 Clinical Trial

Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)

Hyperlipidemia Clinical Trial

Official title:
Vytorin As Strategy To Reduce Dislipidemia In Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00651560
Other study ID # 0653A-148
Secondary ID MK0653A-1482008_
Status Completed
Phase Phase 3
First received
Last updated
Start date November 1, 2005
Est. completion date December 23, 2005

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

This study is intended to allow physicians to check the superior clinical efficacy of Vytorin compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement and cardiovascular risk reduction in adult patients with dislipidemia.

Recruitment information / eligibility
Status Completed
Enrollment 167
Est. completion date December 23, 2005
Est. primary completion date December 23, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients Who Voluntary Accept To Participate In The Study After Been Informed By The Doctor And Signed The Informed Consent Form. Exclusion Criteria: - Any Another Kind Of Contraindication For Use Of Statins - Hypersensitivity To Any Of The Active Ingredients - Increased Serum Hepatic Enzymes (Over 3 Times Only) - Patients With Severe Hepatic Insufficiency - Women who are Pregnant or Potentially Pregnant

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ezetimibe (+) simvastatin
ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the hypolipidemic effect of Vytorin after 4 weeks treatment in adult patients with mix dislipidemia to reduce the cardiovascular risk and achieve the ATP-III goals. After 4 weeks treatment
Secondary To determine the capability of Vytorin to allow adults patients with dislipidemia and previously treated with atorvastatin to get further reduction of the cardiovascular risk and to achieve the ATP-III goals. After 4 weeks treatment
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