Eze/Simva Switch Study in Diabetics (0653A-807) | NCT00541697

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

NCT00541697

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

648Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
Comparator: atorvastatin / Duration of Treatment: 6 Weeks

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2005Actual

Primary Completion Date

Sep 28, 2005Actual

Completion Date

Oct 14, 2005Actual

First Submitted Date

Oct 5, 2007

First Submission Date that Met QC Criteria

Oct 5, 2007

First Posted Date

Oct 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 15, 2024Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

648Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks	Drug
Comparator: atorvastatin / Duration of Treatment: 6 Weeks	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment		6 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17451425	Background	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. doi: 10.1111/j.1463-1326.2007.00725.x. Epub 2007 Apr 19.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000069438	Ezetimibe
D019821	Simvastatin
D000081206	Duration of Therapy

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Type	Description	Link
MK0653A-807
2007_645