Vytorin As Strategy To Reduce Dislipidemia In Adults - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00651560

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia	Drug: ezetimibe (+) simvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Vytorin As Strategy To Reduce Dislipidemia In Adults

Resource links provided by NLM:

Drug Information available for: Simvastatin Ezetimibe Vytorin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	167
Study Start Date:	November 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651560

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_008, MK0653A-148
Study First Received:	March 31, 2008
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00651560 History of Changes
Health Authority:	Ecuador: Public Health Ministry

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Simvastatin
Antilipemic Agents
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors

Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009