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

Phase 3

Completed

• Conditions: Hyperlipidemia

• Registration Number: NCT00651560
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-01
• Primary Completion: 2005-12-23
• Study Completion: 2005-12-23
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-03
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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