Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00300456

First received: March 7, 2006

Last updated: May 29, 2009

Last verified: May 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 7, 2006
Last Updated Date	May 29, 2009
Start Date ^ICMJE	March 2006
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 29, 2009)	Mean 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 ] Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-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 7, 2006)	Triglycerides HDL-C Direct LDL-C
Change History	Complete list of historical versions of study NCT00300456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 29, 2009)	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 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 Total Cholesterol From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as safety issue: No ] Mean Percent Change in Lipoprotein Apo B (Apo B) 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 (submitted: March 7, 2006)	non-HDL-C VLDL-C Total cholesterol Lipoprotein apoB hsCRP
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
Official Title ^ICMJE	A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia
Brief Summary	The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Dyslipidemia Coronary Heart Disease Mixed Dyslipidemia
Intervention ^ICMJE	Drug: ABT-335 135 mg, daily, 12 weeks Other Name: ABT-335 Drug: Simvastatin daily, 12 weeks, see Arm Description for dosage information Other Name: Simvastatin Drug: Placebo Daily, 12 weeks, see Arm Description for placebo information Other Name: Placebo
Study Arm (s)	Active Comparator: A ABT-335 + 20 mg simvastatin Interventions: Drug: ABT-335 Drug: Simvastatin Active Comparator: B ABT-335 + 40 mg simvastatin Interventions: Drug: ABT-335 Drug: Simvastatin Placebo Comparator: C ABT-335 monotherapy Interventions: Drug: ABT-335 Drug: Placebo Placebo Comparator: D 20 mg simvastatin monotherapy Interventions: Drug: Simvastatin Drug: Placebo Placebo Comparator: E 40 mg simvastatin monotherapy Interventions: Drug: Simvastatin Drug: Placebo Placebo Comparator: F 80 mg simvastatin monotherapy Interventions: Drug: Simvastatin Drug: Placebo
Publications *	Bays HE, Roth EM, McKenney JM, Kelly MT, Thakker KM, Setze CM, Obermeyer K, Sleep DJ. The effects of fenofibric acid alone and with statins on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. Diabetes Care. 2010 Sep;33(9):2113-6. Epub 2010 Jun 23. Jones PH, Bays HE, Davidson MH, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme. Clin Drug Investig. 2008;28(10):625-34.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	657
Completion Date	Not Provided
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects with mixed dyslipidemia Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet. Exclusion Criteria: Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial. Patients who are taking certain medications or unstable dose of specific 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 Number ^ICMJE	NCT00300456
Other Study ID Numbers ^ICMJE	M05-749
Has Data Monitoring Committee	No
Responsible Party	Maureen Kelly, MD, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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