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Eze/Simva Switch Study in Diabetics (0653A-807)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00541697
First received: October 5, 2007
Last updated: April 5, 2017
Last verified: April 2017
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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 Intervention Model: Parallel Assignment Masking: Participant, 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
Atorvastatin calcium
Ezetimibe
Atorvastatin calcium trihydrate
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 |
| Actual Study Start Date: | January 19, 2005 |
| Study Completion Date: | October 14, 2005 |
| Primary Completion Date: | September 28, 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
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:
Study Data/Documents: CSR Synopsis
| 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: | April 5, 2017 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Atorvastatin Calcium Simvastatin Ezetimibe |
Ezetimibe, Simvastatin Drug Combination Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on July 21, 2017