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

NCT ID: NCT00651560

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-01
• Study Completion Date: 2005-12-23

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.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ezetimibe (+) simvastatin

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

Intervention Type: DRUG

Other Intervention Names

Vytorin®; MK0653A

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0653A-148

Identifier Type: -

Identifier Source: secondary_id

2008_008

Identifier Type: -

Identifier Source: secondary_id

0653A-148

Identifier Type: -

Identifier Source: org_study_id