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

Tracking Information
First Received Date ^ICMJE	March 14, 2008
Last Updated Date	November 16, 2009
Start Date ^ICMJE	February 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 2, 2009)	Median Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as safety issue: No ] Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 14, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00639158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 2, 2009)	Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ] Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (final visit) ] [ Designated as safety issue: No ] Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ] Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ] Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ] Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
Official Title ^ICMJE	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 compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Dyslipidemias Coronary Heart Disease Combined (Atherogenic) Dyslipidemia Mixed Dyslipidemia
Intervention ^ICMJE	Drug: ABT-335 Drug: placebo Drug: atorvastatin Drug: ezetimibe
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	543
Completion Date
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects with mixed dyslipidemia (trigylcerides, > or = to 150 mg/dL to < 400 mg/dL; HDL-C < 40 mg/dL for males, < 50 mg/dL for females; LDL-C, > or = to 130 mg/dL). Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet. Exclusion Criteria: Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial. Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications. Women who are pregnant or plan on becoming pregnant, or women who are lactating.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00639158
Responsible Party	Maureen Kelly, MD, Abbott
Study ID Numbers ^ICMJE	M10-275
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP