Vytorin As Strategy To Reduce Dislipidemia In Adults

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00651560

First received: March 31, 2008

Last updated: NA

Last verified: March 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 31, 2008

Last Updated Date

March 31, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: After 4 weeks treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: After 4 weeks treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vytorin As Strategy To Reduce Dislipidemia In Adults

Official Title ^ICMJE

Vytorin As Strategy To Reduce Dislipidemia In Adults

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hyperlipidemia

Intervention ^ICMJE

Drug: ezetimibe (+) simvastatin

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

Other Names:

Vytorin®
MK0653A

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

167

Completion Date

Not Provided

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00651560

Other Study ID Numbers ^ICMJE

2008_008, MK0653A-148

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

March 2008

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

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