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.

Study NCT00300456 Information provided by Abbott

First Received on March 7, 2006. Last Updated on May 29, 2009 History of Changes

Results First Received: January 14, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Dyslipidemia Coronary Heart Disease Mixed Dyslipidemia
Interventions:	Drug: ABT-335 Drug: Simvastatin Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven subjects were randomized but never treated: 2 were taking a prohibited concomitant medication, 1 did not meet the entry criteria for lipid levels, 1 had an abnormal baseline electrocardiogram, 1 was unable to swallow pills, and 2 withdrew consent.

Reporting Groups

	Description
ABT-335 + 20 mg Simvastatin	ABT-335 + 20 mg simvastatin combination therapy once daily
ABT-335 + 40 mg Simvastatin	ABT-335 + 40 mg simvastatin combination therapy once daily
ABT-335	ABT-335 monotherapy once daily
20 mg Simvastatin	20 mg simvastatin monotherapy once daily
40 mg Simvastatin	40 mg simvastatin monotherapy once daily
80 mg Simvastatin	80 mg simvastatin monotherapy once daily

Participant Flow: Overall Study

	ABT-335 + 20 mg Simvastatin	ABT-335 + 40 mg Simvastatin	ABT-335	20 mg Simvastatin	40 mg Simvastatin	80 mg Simvastatin
STARTED	119 ^[1]	118	119	119	116	59
COMPLETED	103	102	98	105	99	48
NOT COMPLETED	16	16	21	14	17	11

[1]	For all arms, "started" means treated.

Baseline Characteristics

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Reporting Groups

	Description
ABT-335 + 20 mg Simvastatin	ABT-335 + 20 mg simvastatin combination therapy once daily
ABT-335 + 40 mg Simvastatin	ABT-335 + 40 mg simvastatin combination therapy once daily
ABT-335	ABT-335 monotherapy once daily
20 mg Simvastatin	20 mg simvastatin monotherapy once daily
40 mg Simvastatin	40 mg simvastatin monotherapy once daily
80 mg Simvastatin	80 mg simvastatin monotherapy once daily

Baseline Measures

	ABT-335 + 20 mg Simvastatin	ABT-335 + 40 mg Simvastatin	ABT-335	20 mg Simvastatin	40 mg Simvastatin	80 mg Simvastatin	Total
Number of Participants [units: participants]	119	118	119	119	116	59	650
Age [units: participants]
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	101	96	98	104	104	48	551
>=65 years	18	22	21	15	12	11	99
Gender [units: participants]
Female	59	57	68	56	61	31	332
Male	60	61	51	63	55	28	318
Region of Enrollment [units: participants]
North America	119	118	119	119	116	59	650

Outcome Measures

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1. Primary:

Mean Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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2. Primary:

Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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3. Primary:

Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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4. Secondary:

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) ]

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5. Secondary:

Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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6. Secondary:

Mean Percent Change in Total Cholesterol From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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7. Secondary:

Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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8. Secondary:

Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Not to publish or present the results before the publication of the multi-center investigator paper, but in no event shall be so restricted after the expiration of twelve (12) months from completion of the studies at all sites. Any presentation or publication to be submitted to Sponsor (in draft of the same) for Sponsor review and comment.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Information Specialist
Organization: Abbott
phone: 800-633-9110

No publications provided by Abbott

Publications automatically indexed to this study:

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.

Responsible Party:	Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier:	NCT00300456 History of Changes
Other Study ID Numbers:	M05-749
Study First Received:	March 7, 2006
Results First Received:	January 14, 2009
Last Updated:	May 29, 2009
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada