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

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00639158

First received: March 14, 2008

Last updated: June 9, 2011

Last verified: June 2011

History of Changes

Results First Received: October 2, 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:	Dyslipidemias Coronary Heart Disease Combined (Atherogenic) Dyslipidemia Mixed Dyslipidemia
Interventions:	Drug: ABT-335 Drug: placebo Drug: atorvastatin Drug: ezetimibe

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
One subject was randomized to the atorvastatin and ezetimibe treatment group and never received study drug.

Reporting Groups

	Description
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe	No text entered.
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe	No text entered.

Participant Flow: Overall Study

	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
STARTED	272 ^[1]	270 ^[2]
COMPLETED	246 ^[3]	240 ^[4]
NOT COMPLETED	26	30

[1]	All randomized subjects were treated.
[2]	1 subject was randomized but not treated because of an abnormal ECG that precluded treatment.
[3]	26 subjects prematurely discontinued treatment.
[4]	30 subjects prematurely discontinued treatment

Baseline Characteristics

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Reporting Groups

	Description
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe	No text entered.
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe	No text entered.
Total	Total of all reporting groups

Baseline Measures

	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe	Total
Number of Participants [units: participants]	272	270	542
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	227	206	433
>=65 years	45	64	109
Age [units: years] Mean ± Standard Deviation	54.4 ± 11.23	56.4 ± 10.67	55.4 ± 10.99
Age [units: participants] Mean ± Standard Deviation
United States	54.4 ± 11.23	56.4 ± 10.67	55.4 ± 10.99
Gender [units: participants]
Female	143	155	298
Male	129	115	244

Outcome Measures

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1. Primary:

Median 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. Secondary:

Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ]

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4. 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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5. Secondary:

Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ]

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6. 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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7. Secondary:

Mean Percent Change in Apolipoprotein B (apoB) 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: Global Medical Services
Organization: Abbott
phone: 800-633-9110

No publications provided by Abbott

Publications automatically indexed to this study:

Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66.

Responsible Party:	Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier:	NCT00639158 History of Changes
Other Study ID Numbers:	M10-275
Study First Received:	March 14, 2008
Results First Received:	October 2, 2009
Last Updated:	June 9, 2011
Health Authority:	United States: Food and Drug Administration

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