Safety and Efficacy Study Comparing ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Abnormal Lipid (Fat) Levels in the Blood - Tabular View

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Safety and Efficacy Study Comparing ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Abnormal Lipid (Fat) Levels in the Blood

This study is currently recruiting participants.

Study NCT00639158. Last updated on June 26, 2008. Information provided by Abbott

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Safety and Efficacy Study Comparing ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Abnormal Lipid (Fat) Levels in the Blood

Official Title ^†

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia

Brief Summary

The primary purpose of this study is to test the effect and safety of using an investigational drug regimen containing three medications; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin and once daily ezetimibe to study the effects on patients with abnormal lipid (fat) levels in the blood.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Identify rate of change by measuring baseline levels of triglycerides at various study intervals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Identify rate of change by measuring baseline levels of HDL-C at various study intervals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Condition ^†

Dyslipidemias
Coronary Heart Disease
Combined (Atherogenic) Dyslipidemia
Mixed Dyslipidemia

Intervention ^†

Drug: ABT-335
Drug: placebo
Drug: atorvastatin
Drug: ezetimibe

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

460

Start Date ^†

March 2008

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patients with mixed dyslipidemia.

Exclusion Criteria:

Patients with certain chronic or unstable medical conditions.
Patients with unstable dose of medications or receiving Coumadin, cyclosporine, or certain other medications.
Pregnant or lactating women, or women intending to become pregnant.
Patients with diabetes mellitus that is poorly controlled.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Debra M. Schuerr, BS

847-937-5748

debra.m.schuerr@abbott.com

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00639158

Organization ID

M10-275

Secondary IDs ^††

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Information Provided By

Abbott

Verification Date

June 2008

First Received Date ^†

March 14, 2008

Last Updated Date

June 26, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.