Study to Evaluate the Cholesterol Lowering Effects of Two... | NCT00090298

Studies
Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)

NCT00090298

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

2,815Actual

Phase

Phase 3

Conditions

Hypercholesterolemia

Interventions

MK0653A, ezetimibe (+) simvastatin
Comparator: Rosuvastatin

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
2004_001

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

Apr 2004

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Aug 25, 2004

First Submission Date that Met QC Criteria

Aug 27, 2004

First Posted Date

Aug 30, 2004Estimated

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 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.

Detailed Description

The duration of treatment is 6 weeks.

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

2,815Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LDL-C lowering efficacy after 6 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Safety;changes in TC, non-HDL-C, TG, HDL-C, Apo B, LDL-C/HCL-C ratio.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Men and women aged 18 to 69 years, with elevated cholesterol levels may be eligible to participate in a research study to assess the efficacy and safety of two marketed drugs.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

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
17022864	Background	Catapano AL, Davidson MH, Ballantyne CM, Brady WE, Gazzara RA, Tomassini JE, Tershakovec AM. Lipid-altering efficacy of the ezetimibe/simvastatin single tablet versus rosuvastatin in hypercholesterolemic patients. Curr Med Res Opin. 2006 Oct;22(10):2041-53. doi: 10.1185/030079906X132721.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D000069438	Ezetimibe
D019821	Simvastatin

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

Name	Type	Description	Arm Group Labels	Other Names
MK0653A, ezetimibe (+) simvastatin	Drug
Comparator: Rosuvastatin	Drug