Safety and Efficacy Study Comparing ABT-335 Coadministere... | NCT00639158

Safety and Efficacy Study Comparing ABT-335 Coadministere... | NCT00639158 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABT-335 + atorvastatin + ezetimibe	Active Comparator		Drug: ABT-335 Drug: atorvastatin Drug: ezetimibe
Placebo + atorvastatin + ezetimibe	Placebo Comparator		Drug: placebo Drug: atorvastatin Drug: ezetimibe

Name	Type	Description	Arm Group Labels	Other Names
ABT-335	Drug	135 mg capsule, daily, 12 weeks	ABT-335 + atorvastatin + ezetimibe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Median Percent Change in Triglycerides From Baseline to Final Visit	[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100	Baseline to 12 Weeks (Final Visit)
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit	[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100	Baseline to 12 weeks (Final Visit)

Secondary Outcomes

Measure	Description	Time Frame
Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit	[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100	Baseline to 12 weeks (Final Visit)
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35209	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20934572	Derived	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. doi: 10.1016/j.ahj.2010.06.045.

Results Section

Participant Flow Module

ID	Title	Description
FG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
FG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00054.4± 11.23 BG00156.4± 10.67 BG002

Age Continuous

Mean

Standard Deviation

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00054.4± 11.23 BG00156.4± 10.67 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000143 BG001155 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Median Percent Change in Triglycerides From Baseline to Final Visit

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

All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward.

Posted

Oct 2009

Median

Inter-Quartile Range

Percent change

Baseline to 12 Weeks (Final Visit)

ID	Title	Description
OG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
OG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Units	Counts
Participants	OG000262 OG001262

Title

Denominators

Categories

Title	Measurements
	OG000-57.3± 22.32(-67.1 to -46.3) OG001-39.7± 29.44(-52.5 to -20.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A sample size of 212 per arm provided 90% power and > 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.	Wilcoxon (Mann-Whitney)		< 0.001	The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.						95

Secondary

Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit

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

All randomized subjects with a baseline apoAI value and at least 1 postbaseline apoAI value, last observation carried forward.

Posted

Oct 2009

Mean

Standard Error

Percent change

Baseline to 12 weeks (Final Visit)

ID	Title	Description
OG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
OG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Units	Counts
Participants	OG000

Primary

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

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

All randomized subjects with a baseline high density lipoprotein cholesterol (HDL-C) value and at least 1 postbaseline HDL-C value, last observation carried forward.

Posted

Oct 2009

Mean

Standard Error

Percent change

Baseline to 12 weeks (Final Visit)

ID	Title	Description
OG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
OG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Units	Counts
Participants	OG000

Secondary

Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit

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

All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, last observation carried forward.

Posted

Oct 2009

Mean

Standard Error

Percent change

Baseline to 12 weeks (final visit)

ID	Title	Description
OG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
OG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Units	Counts
Participants	OG000

Secondary

Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit

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

All randomized subjects with a baseline apoCIII value and at least 1 postbaseline apoCIII value, last observation carried forward.

Posted

Oct 2009

Mean

Standard Error

Percent change

Baseline to 12 weeks (Final Visit)

ID	Title	Description
OG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
OG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Units	Counts
Participants	OG000

Secondary

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

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

All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, last observation carried forward.

Posted

Oct 2009

Mean

Standard Error

Percent change

Baseline to 12 weeks (Final Visit)

ID	Title	Description
OG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
OG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Units	Counts
Participants	OG000

Secondary

Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit

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

All randomized subjects with a baseline apoB value and at least 1 postbaseline apoB value, last observation carried forward.

Posted

Oct 2009

Mean

Standard Error

Percent change

Baseline to 12 weeks (Final Visit)

ID	Title	Description
OG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
OG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Units	Counts
Participants	OG000

Secondary

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

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

All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, last observation carried forward.

Posted

Oct 2009

Median

Inter-Quartile Range

Percent change

Baseline to 12 weeks (Final Visit)

ID	Title	Description
OG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
OG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe				3	272	41	272
EG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe				5	270	51	270

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected270 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected270 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected270 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected270 at risk
Chest Pain	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected270 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected270 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected270 at risk
Esophageal Pain	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected270 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected270 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected272 at risk EG0011 affected270 at risk
Wound Infection Staphylococcal	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0001 affected272 at risk EG0010 affected270 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected272 at risk EG00110 affected270 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0009 affected272 at risk EG0016 affected270 at risk
Fatigue	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected272 at risk EG00110 affected270 at risk
Headache	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected272 at risk EG0019 affected270 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG00010 affected272 at risk EG0019 affected270 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0007 affected272 at risk EG00110 affected270 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected272 at risk EG0019 affected270 at risk

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Ancestor Terms

ID	Term
D058607	Fibric Acids
D058610	Isobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010647	Phenyl Ethers
D004987	Ethers
D001577	Benzophenones
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D010636	Phenols
D007659	Ketones
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids
D001384	Azetidines
D001385	Azetines

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.	ANCOVA	Corresponding baseline lipid value as the covariate and with effect for treatment group.	0.004							95						No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A sample size of 212 per arm provided 90% power and > 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.	ANCOVA	Corresponding baseline lipid value as the covariate and with effect for treatment group.	< 0.001	The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.						95						No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.	ANCOVA	Corresponding baseline lipid value as the covariate and with effect for treatment group.	< 0.001							95						No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.	ANCOVA	Corresponding lipid value as the covariate and with effect for treatment group.	< 0.001							95						No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.	ANCOVA	Corresponding baseline lipid value as the covariate and with effect for treatment group.	< 0.001							95						No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.	ANCOVA	Corresponding baseline lipid value as the covariate and with effect for treatment group.	< 0.001							95						No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.	Wilcoxon (Mann-Whitney)	Rank-sum test	< 0.001							95						No	Superiority or Other

ID	Term
D050171	Dyslipidemias
D003327	Coronary Disease

ID	Term
C533234	2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid
D011345	Fenofibrate
C006012	fenofibric acid
D000069059	Atorvastatin
D000069438	Ezetimibe

ID	Title	Description
BG000	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
BG001	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
BG002	Total	Total of all reporting groups