Two Investigational Drugs in Patients With Mixed Hyperlip... | NCT00092560

Studies
Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)

NCT00092560

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

587Actual

Phase

Phase 3

Conditions

Hypercholesterolemia
Hypertriglyceridemia

Interventions

MK0653, ezetimibe
Comparator: fenofibrate monotherapy

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_035

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

Dec 2002

Primary Completion Date

Dec 2003Actual

Completion Date

Dec 2003Actual

First Submitted Date

Sep 23, 2004

First Submission Date that Met QC Criteria

Sep 27, 2004

First Posted Date

Sep 28, 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

The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Detailed Description

The duration of treatment is 18 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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

587Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma LDL-C vs. fenofibrate for 12 weeks.

Secondary Outcomes

Measure	Description	Time Frame
All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High cholesterol and high triglycerides

Exclusion Criteria:

Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
15781429	Background	Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B; Ezetimibe Study Group. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005 May;26(9):897-905. doi: 10.1093/eurheartj/ehi231. Epub 2005 Mar 21.
22087637	Derived

ID	Term
D006937	Hypercholesterolemia
D015228	Hypertriglyceridemia
D006938	Hyperlipoproteinemia Type II

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

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

Name	Type	Description	Arm Group Labels	Other Names
MK0653, ezetimibe	Drug
Comparator: fenofibrate monotherapy	Drug