Eze/Simva Switch Study in Diabetics (0653A-807)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00541697

First received: October 5, 2007

Last updated: November 25, 2014

Last verified: November 2014

History of Changes

Purpose

A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.

Resource links provided by NLM:

Drug Information available for: Simvastatin Atorvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment [ Time Frame: 6 Weeks ]

Secondary Outcome Measures:

Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment [ Time Frame: 6 Weeks ]


Enrollment:	648
Study Start Date:	January 2005
Study Completion Date:	October 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Eligibility


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

Criteria

Inclusion Criteria:

Currently being treated with Atorvastatin 10 mg for at least 6 weeks
Have Type 2 Diabetes
Weight must be stable for more than 6 weeks before entering the study

Exclusion Criteria:

Consume more than 14 alcoholic drinks per week.
Pregnant or lactating
Have taken another investigation drug within 3 months of starting this study
History of congestive heart failure, heart attack, coronary artery bypass surgery
Uncontrolled high blood pressure
HIV positive
History of cancer in the last 5 years

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541697

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

Constance C, Westphal S, Chung N, Lund M, McCrary Sisk C, Johnson-Levonas AO, Massaad R, Allen C. Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2007 Jul;9(4):575-84. Epub 2007 Apr 19.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00541697 History of Changes
Obsolete Identifiers:	NCT00093106
Other Study ID Numbers:	0653A-807, MK0653A-807, 2007_645
Study First Received:	October 5, 2007
Last Updated:	November 25, 2014
Health Authority:	Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:


Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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