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.

Study NCT00639158 Information provided by Abbott

First Received: March 14, 2008 Last Updated: November 16, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Conditions:	Dyslipidemias Coronary Heart Disease Combined (Atherogenic) Dyslipidemia Mixed Dyslipidemia
Interventions:	Drug: ABT-335 Drug: placebo Drug: atorvastatin Drug: ezetimibe

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

Reporting Groups

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

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
Gender [units: participants]
Female	143	155	298
Male	129	115	244
Region of Enrollment [units: participants]
United States	272	270	542

Outcome Measures

1. Primary:

Median Percent Change in Triglycerides From Baseline to Final Visit [ Baseline to 12 Weeks (Final Visit) ]

Show Outcome Measure 1

2. Primary:

Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Baseline to 12 weeks (Final Visit) ]

Show Outcome Measure 2

3. Secondary:

Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit [ 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 [ Baseline to 12 weeks (final visit) ]

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit [ Baseline to 12 weeks (Final Visit) ]

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7. Secondary:

Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit [ Baseline to 12 weeks (Final Visit) ]

Show Outcome Measure 7

8. Secondary:

Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit [ Baseline to 12 weeks (Final Visit) ]

Show Outcome Measure 8