Vytorin Treating Uncontrolled Lipids (VyTUL) Study - Full Text View

Vytorin Treating Uncontrolled Lipids (VyTUL) Study

This study has been terminated.
( This study was terminated early due to poor recruitment. )

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00395603

Purpose

To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.

Condition	Intervention	Phase
Cardiovascular Diseases Diabetes Mellitus	Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks	Phase III

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Atorvastatin Atorvastatin calcium Simvastatin Ezetimibe Vytorin Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage reduction in ldl-c at end-point after 6 weeks.

Estimated Enrollment:	550
Study Start Date:	April 2007
Study Completion Date:	June 2007

Eligibility

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

Criteria

Inclusion Criteria:

Greater than 18 years of age
Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
Existing coronary heart disease and cholesterol > 4.0 mmol/l

Exclusion Criteria:

Uncontrolled diabetes
Elevated liver function tests
Elevated creatine kinase (ck)
Triglycerides (tg) > 4.5 mmol/l
Drug or alcohol dependency within 6 months prior to visit 1
Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
Woman of childbearing potential not using an acceptable method of birth control
Women who are pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395603

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Study ID Numbers:	2006_042
First Received:	November 2, 2006
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00395603
Health Authority:	Australia: National Health and Medical Research Council

Study placed in the following topic categories:

Metabolic Diseases

Heart Diseases

Simvastatin

Diabetes Mellitus

Endocrine System Diseases

Ezetimibe

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Atorvastatin

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Cardiovascular Diseases

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008