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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00300469
• Collaborator: (none)
• Enrollment: 613
• Location: 1
• Arms: 6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)

• atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.

Condition or Disease	Intervention/Treatment	Phase
Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia	Drug: ABT-335; Drug: Atorvastatin; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 613 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A ABT-335 + 20 mg atorvastatin	Drug: ABT-335; 135 mg, daily, 12 weeks; Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information
Active Comparator: B ABT-335 + 40 mg atorvastatin	Drug: ABT-335; 135 mg, daily, 12 weeks; Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information
Placebo Comparator: C ABT-335 monotherapy	Drug: ABT-335; 135 mg, daily, 12 weeks; Drug: Placebo; daily, 12 weeks, see Arm Description for placebo information
Placebo Comparator: D 20 mg atorvastatin monotherapy	Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information; Drug: Placebo; daily, 12 weeks, see Arm Description for placebo information
Placebo Comparator: E 40 mg atorvastatin monotherapy	Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information; Drug: Placebo; daily, 12 weeks, see Arm Description for placebo information
Placebo Comparator: F 80 mg atorvastatin monotherapy	Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information; Drug: Placebo; daily, 12 weeks, see Arm Description for placebo information

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change in Triglycerides From Baseline to Final Visit [Baseline to 12 Weeks (Final Visit)]

   [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100

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

   [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100

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

   [(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100

Secondary Outcome Measures

1. Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit [Baseline to 12 Weeks (Final Visit)]

   [(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100

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

   [(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100

3. Mean Percent Change in Total Cholesterol From Baseline to Final Visit [Baseline to 12 Weeks (Final Visit)]

   [(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100

4. Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit [Baseline to 12 Weeks (Final Visit)]

   [(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100

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

   [(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with mixed dyslipidemia

• Subjects must 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Global Medical Information	North Chicago	Illinois	United States	60064

Sponsors and Collaborators

• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00300469
• Other Study ID Numbers: M05-750
• First Posted: Mar 9, 2006
• Last Update Posted: Jun 3, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia
• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Dyslipidemias; Atorvastatin

Study Results

Participant Flow

Pre-assignment Detail	Four subjects were randomized but never treated: 2 were randomized but were deemed ineligible, 1 had a history of allergic reactions to statins, and 1 was noncompliant and never received study drug.

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Period Title: Overall Study
STARTED	110	110	112	113	109	55
COMPLETED	89	89	95	104	95	46
NOT COMPLETED	21	21	17	9	14	9

Baseline Characteristics

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin	Total
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily	Total of all reporting groups
Overall Participants	110	110	112	113	109	55	609
Age (Count of Participants)
<=18 years	0 0%	1 0.9%	0 0%	0 0%	0 0%	0 0%	1 0.2%
Between 18 and 65 years	87 79.1%	83 75.5%	95 84.8%	93 82.3%	87 79.8%	44 80%	489 80.3%
>=65 years	23 20.9%	26 23.6%	17 15.2%	20 17.7%	22 20.2%	11 20%	119 19.5%
Sex: Female, Male (Count of Participants)
Female	56 50.9%	61 55.5%	57 50.9%	48 42.5%	60 55%	29 52.7%	311 51.1%
Male	54 49.1%	49 44.5%	55 49.1%	65 57.5%	49 45%	26 47.3%	298 48.9%
Region of Enrollment (participants) [Number]
North America	110 100%	110 100%	112 100%	113 100%	109 100%	55 100%	609 100%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change in Triglycerides From Baseline to Final Visit
Description	[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
Time Frame	Baseline to 12 Weeks (Final Visit)

Outcome Measure Data

Analysis Population Description

All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward (excluding one subject with an extreme outlying value)

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Measure Participants	105	102	104	108	105	52
Mean (Standard Error) [percent change]	-45.6 (3.36)	-42.1 (3.40)	-29.6 (3.35)	-16.5 (3.31)	-23.2 (3.35)	-30.4 (4.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-335 + 20 mg Atorvastatin, 20 mg Atorvastatin
	Comments	An n = 92 per arm would provide >99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABT-335 + 40 mg Atorvastatin, 40 mg Atorvastatin
	Comments	An n = 92 per arm would provide >99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
Description	[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
Time Frame	Baseline to 12 Weeks (Final Visit)

Outcome Measure Data

Analysis Population Description

All randomized subjects with a baseline HDL-C value and at least 1 postbasline HDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Measure Participants	95	91	93	101	92	50
Mean (Standard Error) [percent change]	14.0 (2.02)	12.6 (2.08)	19.9 (2.04)	6.3 (1.96)	5.3 (2.05)	6.2 (2.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-335 + 20 mg Atorvastatin, 20 mg Atorvastatin
	Comments	An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments	alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABT-335 + 40 mg Atorvastatin, 40 mg Atorvastatin
	Comments	An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.010
	Comments	alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
	Method	ANCOVA
	Comments

3. Primary Outcome

Title	Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
Description	[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100
Time Frame	Baseline to 12 Weeks (Final Visit)

Outcome Measure Data

Analysis Population Description

All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Measure Participants	97	96	97	103	95	50
Mean (Standard Error) [percent change]	-33.7 (1.91)	-35.4 (1.93)	-3.4 (1.90)	-37.1 (1.85)	-39.7 (1.92)	-46.0 (2.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-335 + 20 mg Atorvastatin, ABT-335
	Comments	An n = 92 per arm would provide >99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABT-335 + 40 mg Atorvastatin, ABT-335
	Comments	An n = 92 per arm would provide >99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit
Description	[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100
Time Frame	Baseline to 12 Weeks (Final Visit)

Outcome Measure Data

Analysis Population Description

All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Measure Participants	95	91	93	102	92	50
Mean (Standard Error) [percent change]	-40.8 (1.69)	-42.5 (1.74)	-14.8 (1.71)	-35.7 (1.64)	-41.7 (1.72)	-45.2 (2.30)

5. Secondary Outcome

Title	Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
Description	[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100
Time Frame	Baseline to 12 Weeks (Final Visit)

Outcome Measure Data

Analysis Population Description

All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Measure Participants	103	101	104	107	105	52
Mean (Standard Error) [percent change]	-48.3 (3.72)	-53.5 (3.74)	-36.5 (3.66)	-26.2 (3.63)	-35.6 (3.66)	-38.9 (5.13)

6. Secondary Outcome

Title	Mean Percent Change in Total Cholesterol From Baseline to Final Visit
Description	[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100
Time Frame	Baseline to 12 Weeks (Final Visit)

Outcome Measure Data

Analysis Population Description

All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Measure Participants	105	102	104	109	105	52
Mean (Standard Error) [percent change]	-32.8 (1.32)	-34.6 (1.33)	-10.1 (1.32)	-29.6 (1.29)	-33.8 (1.31)	-38.2 (1.84)

7. Secondary Outcome

Title	Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
Description	[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100
Time Frame	Baseline to 12 Weeks (Final Visit)

Outcome Measure Data

Analysis Population Description

All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Measure Participants	104	101	104	109	104	52
Mean (Standard Error) [percent change]	-37.0 (1.49)	-37.1 (1.52)	-12.4 (1.49)	-32.9 (1.46)	-35.3 (1.50)	-40.3 (2.08)

8. Secondary Outcome

Title	Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
Description	[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100
Time Frame	Baseline to 12 Weeks (Final Visit)

Outcome Measure Data

Analysis Population Description

All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF

Arm/Group Title	ABT-335 + 20 mg Atorvastatin	ABT-335 + 40 mg Atorvastatin	ABT-335	20 mg Atorvastatin	40 mg Atorvastatin	80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily	ABT-335 + 40 mg atorvastatin combination therapy once daily	ABT-335 monotherapy once daily	20 mg atorvastatin monotherapy once daily	40 mg atorvastatin monotherapy once daily	80 mg atorvastatin monotherapy once daily
Measure Participants	104	101	104	109	104	52
Median (Inter-Quartile Range) [percent change]	-26.2 (24.76)	-42.9 (25.11)	-12.4 (24.65)	-29.6 (24.18)	-30.3 (25.08)	-31.9 (34.50)

Adverse Events

Arm/Group Title	ABT-335 + 20 mg Atorvastatin		ABT-335 + 40 mg Atorvastatin		ABT-335		20 mg Atorvastatin		40 mg Atorvastatin		80 mg Atorvastatin
Arm/Group Description	ABT-335 + 20 mg atorvastatin combination therapy once daily		ABT-335 + 40 mg atorvastatin combination therapy once daily		ABT-335 monotherapy once daily		20 mg atorvastatin monotherapy once daily		40 mg atorvastatin monotherapy once daily		80 mg atorvastatin monotherapy once daily
All Cause Mortality
	ABT-335 + 20 mg Atorvastatin		ABT-335 + 40 mg Atorvastatin		ABT-335		20 mg Atorvastatin		40 mg Atorvastatin		80 mg Atorvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ABT-335 + 20 mg Atorvastatin		ABT-335 + 40 mg Atorvastatin		ABT-335		20 mg Atorvastatin		40 mg Atorvastatin		80 mg Atorvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/ (NaN)		2/ (NaN)		3/ (NaN)		2/ (NaN)		2/ (NaN)		2/ (NaN)
Cardiac disorders
Coronary artery disease	0/110 (0%)		0/110 (0%)		1/112 (0.9%)		0/113 (0%)		0/109 (0%)		0/55 (0%)
Wolff-Parkinson-White syndrome	0/110 (0%)		0/110 (0%)		0/112 (0%)		1/113 (0.9%)		0/109 (0%)		0/55 (0%)
Gastrointestinal disorders
Abdominal hernia	0/110 (0%)		0/110 (0%)		0/112 (0%)		0/113 (0%)		0/109 (0%)		1/55 (1.8%)
Crohn's disease	0/110 (0%)		0/110 (0%)		0/112 (0%)		0/113 (0%)		1/109 (0.9%)		0/55 (0%)
Hepatobiliary disorders
Cholecystitis	0/110 (0%)		1/110 (0.9%)		0/112 (0%)		0/113 (0%)		0/109 (0%)		0/55 (0%)
Cholelithiasis	0/110 (0%)		1/110 (0.9%)		0/112 (0%)		0/113 (0%)		0/109 (0%)		0/55 (0%)
Infections and infestations
Abscess jaw	0/110 (0%)		0/110 (0%)		0/112 (0%)		0/113 (0%)		1/109 (0.9%)		0/55 (0%)
Parotitis	0/110 (0%)		0/110 (0%)		0/112 (0%)		0/113 (0%)		1/109 (0.9%)		0/55 (0%)
Injury, poisoning and procedural complications
Accidental overdose	0/110 (0%)		1/110 (0.9%)		0/112 (0%)		0/113 (0%)		0/109 (0%)		0/55 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder	0/110 (0%)		0/110 (0%)		0/112 (0%)		0/113 (0%)		0/109 (0%)		1/55 (1.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	0/110 (0%)		0/110 (0%)		1/112 (0.9%)		0/113 (0%)		0/109 (0%)		0/55 (0%)
Nervous system disorders
Sciatica	0/110 (0%)		0/110 (0%)		0/112 (0%)		1/113 (0.9%)		0/109 (0%)		0/55 (0%)
Syncope	1/110 (0.9%)		0/110 (0%)		0/112 (0%)		0/113 (0%)		0/109 (0%)		0/55 (0%)
Vascular disorders
Deep vein thrombosis	0/110 (0%)		0/110 (0%)		1/112 (0.9%)		0/113 (0%)		0/109 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	ABT-335 + 20 mg Atorvastatin		ABT-335 + 40 mg Atorvastatin		ABT-335		20 mg Atorvastatin		40 mg Atorvastatin		80 mg Atorvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	50/ (NaN)		50/ (NaN)		50/ (NaN)		45/ (NaN)		57/ (NaN)		33/ (NaN)
Gastrointestinal disorders
Abdominal pain upper	3/110 (2.7%)		2/110 (1.8%)		3/112 (2.7%)		2/113 (1.8%)		2/109 (1.8%)		2/55 (3.6%)
Constipation	3/110 (2.7%)		4/110 (3.6%)		1/112 (0.9%)		2/113 (1.8%)		1/109 (0.9%)		1/55 (1.8%)
Diarrhea	6/110 (5.5%)		5/110 (4.5%)		7/112 (6.3%)		5/113 (4.4%)		7/109 (6.4%)		7/55 (12.7%)
Dyspepsia	3/110 (2.7%)		3/110 (2.7%)		1/112 (0.9%)		1/113 (0.9%)		4/109 (3.7%)		0/55 (0%)
Nausea	5/110 (4.5%)		8/110 (7.3%)		4/112 (3.6%)		2/113 (1.8%)		6/109 (5.5%)		4/55 (7.3%)
Toothache	3/110 (2.7%)		1/110 (0.9%)		4/112 (3.6%)		2/113 (1.8%)		2/109 (1.8%)		1/55 (1.8%)
Vomiting	2/110 (1.8%)		2/110 (1.8%)		2/112 (1.8%)		0/113 (0%)		0/109 (0%)		4/55 (7.3%)
General disorders
Fatigue	1/110 (0.9%)		2/110 (1.8%)		0/112 (0%)		3/113 (2.7%)		6/109 (5.5%)		0/55 (0%)
Edema peripheral	2/110 (1.8%)		0/110 (0%)		2/112 (1.8%)		0/113 (0%)		7/109 (6.4%)		2/55 (3.6%)
Pain	4/110 (3.6%)		4/110 (3.6%)		3/112 (2.7%)		1/113 (0.9%)		1/109 (0.9%)		2/55 (3.6%)
Infections and infestations
Bronchitis	0/110 (0%)		1/110 (0.9%)		0/112 (0%)		0/113 (0%)		1/109 (0.9%)		2/55 (3.6%)
Gastroenteritis viral	0/110 (0%)		1/110 (0.9%)		1/112 (0.9%)		0/113 (0%)		1/109 (0.9%)		3/55 (5.5%)
Influenza	1/110 (0.9%)		3/110 (2.7%)		0/112 (0%)		4/113 (3.5%)		1/109 (0.9%)		1/55 (1.8%)
Nasopharyngitis	4/110 (3.6%)		3/110 (2.7%)		4/112 (3.6%)		4/113 (3.5%)		4/109 (3.7%)		3/55 (5.5%)
Sinusitis	2/110 (1.8%)		5/110 (4.5%)		3/112 (2.7%)		2/113 (1.8%)		2/109 (1.8%)		1/55 (1.8%)
Upper respiratory tract infection	4/110 (3.6%)		3/110 (2.7%)		9/112 (8%)		2/113 (1.8%)		6/109 (5.5%)		0/55 (0%)
Investigations
Alanine aminotransferase increased	6/110 (5.5%)		1/110 (0.9%)		1/112 (0.9%)		0/113 (0%)		0/109 (0%)		2/55 (3.6%)
Aspartate aminotransferase increased	6/110 (5.5%)		1/110 (0.9%)		1/112 (0.9%)		0/113 (0%)		0/109 (0%)		2/55 (3.6%)
Blood alkaline phosphatase increased	1/110 (0.9%)		0/110 (0%)		0/112 (0%)		0/113 (0%)		2/109 (1.8%)		2/55 (3.6%)
Blood creatine phosphokinase increased	4/110 (3.6%)		0/110 (0%)		0/112 (0%)		0/113 (0%)		1/109 (0.9%)		2/55 (3.6%)
Hepatic enzyme increased	4/110 (3.6%)		5/110 (4.5%)		1/112 (0.9%)		0/113 (0%)		1/109 (0.9%)		1/55 (1.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/110 (2.7%)		2/110 (1.8%)		6/112 (5.4%)		2/113 (1.8%)		6/109 (5.5%)		1/55 (1.8%)
Back pain	5/110 (4.5%)		1/110 (0.9%)		5/112 (4.5%)		5/113 (4.4%)		6/109 (5.5%)		0/55 (0%)
Muscle spasms	4/110 (3.6%)		4/110 (3.6%)		3/112 (2.7%)		4/113 (3.5%)		4/109 (3.7%)		1/55 (1.8%)
Myalgia	2/110 (1.8%)		5/110 (4.5%)		3/112 (2.7%)		5/113 (4.4%)		8/109 (7.3%)		3/55 (5.5%)
Pain in extremity	3/110 (2.7%)		3/110 (2.7%)		2/112 (1.8%)		4/113 (3.5%)		6/109 (5.5%)		2/55 (3.6%)
Nervous system disorders
Dizziness	3/110 (2.7%)		7/110 (6.4%)		3/112 (2.7%)		1/113 (0.9%)		4/109 (3.7%)		0/55 (0%)
Headache	13/110 (11.8%)		10/110 (9.1%)		14/112 (12.5%)		17/113 (15%)		14/109 (12.8%)		7/55 (12.7%)
Somnolence	1/110 (0.9%)		0/110 (0%)		1/112 (0.9%)		0/113 (0%)		1/109 (0.9%)		2/55 (3.6%)
Psychiatric disorders
Insomnia	1/110 (0.9%)		1/110 (0.9%)		3/112 (2.7%)		1/113 (0.9%)		2/109 (1.8%)		2/55 (3.6%)
Respiratory, thoracic and mediastinal disorders
Cough	1/110 (0.9%)		1/110 (0.9%)		2/112 (1.8%)		2/113 (1.8%)		1/109 (0.9%)		3/55 (5.5%)
Pharyngolaryngeal pain	2/110 (1.8%)		5/110 (4.5%)		3/112 (2.7%)		4/113 (3.5%)		4/109 (3.7%)		0/55 (0%)
Rhinorrhea	1/110 (0.9%)		0/110 (0%)		3/112 (2.7%)		1/113 (0.9%)		1/109 (0.9%)		2/55 (3.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.