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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.
Verified by Abbott, June 2008

Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00639158
  Purpose

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.


Condition Intervention Phase
Dyslipidemias
Coronary Heart Disease
Combined (Atherogenic) Dyslipidemia
Mixed Dyslipidemia
Drug: ABT-335
Drug: placebo
Drug: atorvastatin
Drug: ezetimibe
Phase III

MedlinePlus related topics:   Heart Diseases   

ChemIDplus related topics:   Atorvastatin    Atorvastatin calcium    Ezetimibe    Lipids   

U.S. FDA Resources

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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   460
Study Start Date:   March 2008
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
ABT-335, atorvastatin, ezetimibe
Drug: ABT-335
135 mg capsule, daily, 12 weeks
Drug: atorvastatin
40 mg, tablet, daily, 12 weeks
Drug: ezetimibe
10 mg capsule, daily, 12 weeks
B: Placebo Comparator
placebo, atorvastatin, ezetimibe
Drug: placebo
placebo capsule, daily, 12 weeks

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639158

Contacts
Contact: Debra M. Schuerr, BS     847-937-5748     debra.m.schuerr@abbott.com    

Show 108 study locations  Show 108 Study Locations

Sponsors and Collaborators
Abbott
  More Information

Responsible Party:   Abbott ( Maureen Kelly, MD )
Study ID Numbers:   M10-275
First Received:   March 14, 2008
Last Updated:   June 26, 2008
ClinicalTrials.gov Identifier:   NCT00639158
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Coronary Disease
Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ezetimibe
Ischemia
Metabolic disorder
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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