Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A... | NCT00395603

Studies
Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)

NCT00395603

Sponsor

Organon and Co

Status

Terminated

Last Update Posted

Aug 15, 2024Actual

Enrollment

550Estimated

Phase

Phase 3

Conditions

Cardiovascular Diseases
Diabetes Mellitus

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

ID	Type	Description	Link
2006_042

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was terminated early due to poor recruitment.

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Nov 2, 2006

First Submission Date that Met QC Criteria

Nov 2, 2006

First Posted Date

Nov 3, 2006Estimated

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

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.

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

550Estimated

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

Measure	Description	Time Frame
Percentage reduction in ldl-c at end-point after 6 weeks.

Eligibility Module

Eligibility 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

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

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069438	Ezetimibe
D019821	Simvastatin
D000081206	Duration of Therapy

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided