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

This study has been completed.

Study NCT00300482 Information provided by Abbott

First Received on March 7, 2006. Last Updated on June 3, 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, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Dyslipidemia Coronary Heart Disease Mixed Dyslipidemia
Interventions:	Drug: ABT-335 Drug: Rosuvastatin Calcium 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
Six subjects were randomized but not treated: 1 was lost to follow-up, 1 was randomized but deemed ineligible, 1 was withdrawn at the investigator's discretion, and 3 withdrew consent.

Reporting Groups

	Description
ABT-335 + 10 mg Rosuvastatin	ABT-335 + 10 mg rosuvastatin combination therapy once daily
ABT-335 + 20 mg Rosuvastatin	ABT-335 + 20 mg rosuvastatin combination therapy once daily
ABT-335	ABT-335 monotherapy once daily
10 mg Rosuvastatin	10 mg rosuvastatin monotherapy once daily
20 mg Rosuvastatin	20 mg rosuvastatin monotherapy once daily
40 mg Rosuvastatin	40 mg rosuvastatin monotherapy once daily

Participant Flow: Overall Study

	ABT-335 + 10 mg Rosuvastatin	ABT-335 + 20 mg Rosuvastatin	ABT-335	10 mg Rosuvastatin	20 mg Rosuvastatin	40 mg Rosuvastatin
STARTED	261 ^[1]	261	259	261	266	131
COMPLETED	220	220	208	237	243	115
NOT COMPLETED	41	41	51	24	23	16

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

Baseline Characteristics

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Reporting Groups

	Description
ABT-335 + 10 mg Rosuvastatin	ABT-335 + 10 mg rosuvastatin combination therapy once daily
ABT-335 + 20 mg Rosuvastatin	ABT-335 + 20 mg rosuvastatin combination therapy once daily
ABT-335	ABT-335 monotherapy once daily
10 mg Rosuvastatin	10 mg rosuvastatin monotherapy once daily
20 mg Rosuvastatin	20 mg rosuvastatin monotherapy once daily
40 mg Rosuvastatin	40 mg rosuvastatin monotherapy once daily

Baseline Measures

	ABT-335 + 10 mg Rosuvastatin	ABT-335 + 20 mg Rosuvastatin	ABT-335	10 mg Rosuvastatin	20 mg Rosuvastatin	40 mg Rosuvastatin	Total
Number of Participants [units: participants]	261	261	259	261	266	131	1439
Age [units: participants]
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	206	209	209	222	217	103	1166
>=65 years	55	52	50	39	49	28	273
Gender [units: participants]
Female	148	131	152	130	124	65	750
Male	113	130	107	131	142	66	689
Region of Enrollment [units: participants]
North America	261	261	259	261	266	131	1439

Outcome Measures

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1. Primary:

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

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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 ]

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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 ]

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4. Secondary:

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

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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 ]

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6. Secondary:

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

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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 ]

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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 ]

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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:

Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57.

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, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. Epub 2008 Oct 5.

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:	NCT00300482 History of Changes
Other Study ID Numbers:	M05-748
Study First Received:	March 7, 2006
Results First Received:	January 14, 2009
Last Updated:	June 3, 2009
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada