Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00812955
• Collaborator: (none)
• Enrollment: 474
• Locations: 129
• Arms: 4
• Duration (Months): 7
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia	Drug: ABT-143; Drug: simvastatin	Phase 3

Detailed Description

There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.

Study Design

• Study Type: Interventional
• Actual Enrollment: 474 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: An 8-Week, Multicenter, Randomized, Double-blind, Four-arm, Parallel-group Study Comparing the Safety and Efficacy of ABT-143 to Simvastatin in Subjects With Hypercholesterolemia
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A - ABT-143 capsules 5/135 mg ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks	Drug: ABT-143; Once daily for 8 weeks
Experimental: B - ABT-143 capsules 10/135 mg ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks	Drug: ABT-143; Once daily for 8 weeks
Experimental: C - ABT-143 capsules 20/135 mg ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks	Drug: ABT-143; Once daily for 8 weeks
Active Comparator: D - Simvastatin capsules 40 mg Simvastatin capsules 40 mg daily for 8 weeks	Drug: simvastatin; Once daily for 8 weeks simvastatin capsules 40 mg

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) [Baseline to 8 weeks]

   The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.

Secondary Outcome Measures

1. Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) [Baseline to 8 weeks]

   The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.

2. Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) [Baseline to 8 weeks]

   The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.

Other Outcome Measures

1. Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) [Baseline to 8 weeks]

   The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set.

2. Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set) [Baseline to 8 weeks]

   The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set.

Eligibility Criteria

Criteria

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

Inclusion Criteria

• Participants with hypercholesterolemia and hypertriglyceridemia.

• Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)):

• Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and less than 400 milligrams/deciliter, and

• Low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter.

Exclusion Criteria

• Participants with certain chronic or unstable medical conditions.

• Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications.

• Pregnant or lactating women, or women intending to become pregnant.

• Participants with diabetes mellitus that is poorly controlled.

• Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 12654	Birmingham	Alabama	United States	35235
2	Site Reference ID/Investigator# 12634	Columbiana	Alabama	United States	35051
3	Site Reference ID/Investigator# 12559	Huntsville	Alabama	United States	35801
4	Site Reference ID/Investigator# 12499	Ozark	Alabama	United States	36360
5	Site Reference ID/Investigator# 12673	Chandler	Arizona	United States	85225
6	Site Reference ID/Investigator# 17282	Scottsdale	Arizona	United States	85251
7	Site Reference ID/Investigator# 12657	Little Rock	Arkansas	United States	72204
8	Site Reference ID/Investigator# 12489	Anaheim	California	United States	92804
9	Site Reference ID/Investigator# 12495	Carmichael	California	United States	95608
10	Site Reference ID/Investigator# 12467	Chula Vista	California	United States	91911
11	Site Reference ID/Investigator# 12498	Long Beach	California	United States	90806
12	Site Reference ID/Investigator# 12602	Los Angeles	California	United States	90057
13	Site Reference ID/Investigator# 12510	Norwalk	California	United States	90650
14	Site Reference ID/Investigator# 12550	Palm Desert	California	United States	92260
15	Site Reference ID/Investigator# 16503	Roseville	California	United States	95661
16	Site Reference ID/Investigator# 12678	Sacramento	California	United States	95825
17	Site Reference ID/Investigator# 14241	Sacramento	California	United States	95825
18	Site Reference ID/Investigator# 12473	San Diego	California	United States	92123
19	Site Reference ID/Investigator# 12497	Walnut Creek	California	United States	94598
20	Site Reference ID/Investigator# 12680	West Hills	California	United States	91307
21	Site Reference ID/Investigator# 12461	Colorado Springs	Colorado	United States	80904
22	Site Reference ID/Investigator# 12600	Colorado Springs	Colorado	United States	80909
23	Site Reference ID/Investigator# 12679	Waterbury	Connecticut	United States	06708
24	Site Reference ID/Investigator# 12598	Clearwater	Florida	United States	33756
25	Site Reference ID/Investigator# 15542	Coral Gables	Florida	United States	33134
26	Site Reference ID/Investigator# 12477	Daytona Beach	Florida	United States	32117
27	Site Reference ID/Investigator# 12668	Delray Beach	Florida	United States	33484
28	Site Reference ID/Investigator# 15483	Fort Lauderdale	Florida	United States	33306
29	Site Reference ID/Investigator# 12645	Fort Myers	Florida	United States	33907
30	Site Reference ID/Investigator# 12672	Hollywood	Florida	United States	33023
31	Site Reference ID/Investigator# 17504	Jacksonville	Florida	United States	32205
32	Site Reference ID/Investigator# 12781	Jacksonville	Florida	United States	32259
33	Site Reference ID/Investigator# 12665	Jupiter	Florida	United States	33458-7200
34	Site Reference ID/Investigator# 12682	Longwood	Florida	United States	32779
35	Site Reference ID/Investigator# 15486	Melbourne	Florida	United States	32935
36	Site Reference ID/Investigator# 12502	New Port Richey	Florida	United States	34652
37	Site Reference ID/Investigator# 12647	Ocala	Florida	United States	34471
38	Site Reference ID/Investigator# 12520	Orlando	Florida	United States	32806
39	Site Reference ID/Investigator# 12687	Ormond Beach	Florida	United States	32174
40	Site Reference ID/Investigator# 12583	Sarasota	Florida	United States	34233
41	Site Reference ID/Investigator# 12652	Tampa	Florida	United States	33607
42	Site Reference ID/Investigator# 12557	West Palm Beach	Florida	United States	33401
43	Site Reference ID/Investigator# 12621	Winter Haven	Florida	United States	33880
44	Site Reference ID/Investigator# 16505	Winter Park	Florida	United States	32792
45	Site Reference ID/Investigator# 12675	Augusta	Georgia	United States	30909
46	Site Reference ID/Investigator# 12620	Dunwoody	Georgia	United States	30338
47	Site Reference ID/Investigator# 12653	Roswell	Georgia	United States	30076
48	Site Reference ID/Investigator# 12555	Suwanee	Georgia	United States	30024
49	Site Reference ID/Investigator# 12787	Woodstock	Georgia	United States	30189
50	Site Reference ID/Investigator# 12514	Chicago	Illinois	United States	60654
51	Site Reference ID/Investigator# 12487	Peoria	Illinois	United States	61602
52	Site Reference ID/Investigator# 12627	Peoria	Illinois	United States	61614
53	Site Reference ID/Investigator# 12529	Evansville	Indiana	United States	47714
54	Site Reference ID/Investigator# 12688	Indianapolis	Indiana	United States	46260
55	Site Reference ID/Investigator# 15485	South Bend	Indiana	United States	46601
56	Site Reference ID/Investigator# 12676	Arkansas City	Kansas	United States	67005
57	Site Reference ID/Investigator# 12597	Wichita	Kansas	United States	67203
58	Site Reference ID/Investigator# 12472	Louisville	Kentucky	United States	40213
59	Site Reference ID/Investigator# 12658	Mount Sterling	Kentucky	United States	40353
60	Site Reference ID/Investigator# 12586	Baltimore	Maryland	United States	21209
61	Site Reference ID/Investigator# 12480	Bethesda	Maryland	United States	20817
62	Site Reference ID/Investigator# 12638	Oxon Hill	Maryland	United States	20745
63	Site Reference ID/Investigator# 12513	Springfield	Massachusetts	United States	01103
64	Site Reference ID/Investigator# 12663	Kalamazoo	Michigan	United States	49009
65	Site Reference ID/Investigator# 12609	Brooklyn Center	Minnesota	United States	55430
66	Site Reference ID/Investigator# 16622	Edina	Minnesota	United States	55435
67	Site Reference ID/Investigator# 12625	Jackson	Mississippi	United States	39202
68	Site Reference ID/Investigator# 12560	Olive Branch	Mississippi	United States	38654
69	Site Reference ID/Investigator# 12677	St. Louis	Missouri	United States	63141
70	Site Reference ID/Investigator# 12534	St. Peters	Missouri	United States	63376
71	Site Reference ID/Investigator# 12592	Billings	Montana	United States	59101
72	Site Reference ID/Investigator# 12655	Omaha	Nebraska	United States	68131
73	Site Reference ID/Investigator# 12587	Las Vegas	Nevada	United States	89123
74	Site Reference ID/Investigator# 12554	Berlin	New Jersey	United States	08009
75	Site Reference ID/Investigator# 12637	Elizabeth	New Jersey	United States	07202
76	Site Reference ID/Investigator# 12463	Hillsborough	New Jersey	United States	08844
77	Site Reference ID/Investigator# 12660	Trenton	New Jersey	United States	08611
78	Site Reference ID/Investigator# 12506	Albuquerque	New Mexico	United States	87108
79	Site Reference ID/Investigator# 12539	Johnson City	New York	United States	13790
80	Site Reference ID/Investigator# 12631	Syracuse	New York	United States	13202
81	Site Reference ID/Investigator# 17503	Cary	North Carolina	United States	27518
82	Site Reference ID/Investigator# 12650	Charlotte	North Carolina	United States	28209
83	Site Reference ID/Investigator# 12504	Charlotte	North Carolina	United States	28211
84	Site Reference ID/Investigator# 12558	Charlotte	North Carolina	United States	28262
85	Site Reference ID/Investigator# 12671	Charlotte	North Carolina	United States	28277
86	Site Reference ID/Investigator# 12527	Hickory	North Carolina	United States	28601
87	Site Reference ID/Investigator# 12608	Morehead City	North Carolina	United States	28557
88	Site Reference ID/Investigator# 12535	Salisbury	North Carolina	United States	28144
89	Site Reference ID/Investigator# 12656	Statesville	North Carolina	United States	28677
90	Site Reference ID/Investigator# 17641	Wilmington	North Carolina	United States	28401
91	Site Reference ID/Investigator# 12606	Winston-Salem	North Carolina	United States	27103
92	Site Reference ID/Investigator# 12614	Akron	Ohio	United States	44311
93	Site Reference ID/Investigator# 12662	Cincinnati	Ohio	United States	45219
94	Site Reference ID/Investigator# 12545	Cincinnati	Ohio	United States	45242
95	Site Reference ID/Investigator# 12640	Kettering	Ohio	United States	45429
96	Site Reference ID/Investigator# 12786	Mason	Ohio	United States	45040
97	Site Reference ID/Investigator# 12630	Warren	Ohio	United States	44483
98	Site Reference ID/Investigator# 12551	Oklahoma City	Oklahoma	United States	73112
99	Site Reference ID/Investigator# 12611	Tulsa	Oklahoma	United States	74136
100	Site Reference ID/Investigator# 12585	Medford	Oregon	United States	97504
101	Site Reference ID/Investigator# 12610	Beaver	Pennsylvania	United States	15009
102	Site Reference ID/Investigator# 12589	Duncansville	Pennsylvania	United States	16635
103	Site Reference ID/Investigator# 12607	Harleysville	Pennsylvania	United States	19438-2513
104	Site Reference ID/Investigator# 12641	Jersey Shore	Pennsylvania	United States	17740
105	Site Reference ID/Investigator# 12507	Melrose Park	Pennsylvania	United States	19027
106	Site Reference ID/Investigator# 12624	Perkasie	Pennsylvania	United States	18944
107	Site Reference ID/Investigator# 12669	Philadelphia	Pennsylvania	United States	19114
108	Site Reference ID/Investigator# 12788	Philadelphia	Pennsylvania	United States	19152
109	Site Reference ID/Investigator# 12525	Pittsburgh	Pennsylvania	United States	15216
110	Site Reference ID/Investigator# 12601	Tipton	Pennsylvania	United States	16684
111	Site Reference ID/Investigator# 12686	Warminster	Pennsylvania	United States	18974
112	Site Reference ID/Investigator# 12623	Mount Pleasant	South Carolina	United States	29464
113	Site Reference ID/Investigator# 12681	Mount Pleasant	South Carolina	United States	29464
114	Site Reference ID/Investigator# 12485	Simpsonville	South Carolina	United States	29681
115	Site Reference ID/Investigator# 12639	Summerville	South Carolina	United States	29485
116	Site Reference ID/Investigator# 15642	Germantown	Tennessee	United States	38138
117	Site Reference ID/Investigator# 12643	Jackson	Tennessee	United States	38305
118	Site Reference ID/Investigator# 12470	Dallas	Texas	United States	75230
119	Site Reference ID/Investigator# 16081	Dallas	Texas	United States	75234
120	Site Reference ID/Investigator# 12492	Dallas	Texas	United States	75251
121	Site Reference ID/Investigator# 12464	Fort Worth	Texas	United States	76104
122	Site Reference ID/Investigator# 12646	San Antonio	Texas	United States	78205
123	Site Reference ID/Investigator# 16601	San Antonio	Texas	United States	78215
124	Site Reference ID/Investigator# 12540	San Antonio	Texas	United States	78224
125	Site Reference ID/Investigator# 12466	San Antonio	Texas	United States	78229
126	Site Reference ID/Investigator# 12622	San Antonio	Texas	United States	78229
127	Site Reference ID/Investigator# 12538	Norfolk	Virginia	United States	23502-9921
128	Site Reference ID/Investigator# 12616	Richmond	Virginia	United States	23294
129	Site Reference ID/Investigator# 12476	Madison	Wisconsin	United States	53719

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Torbjörn Lundström, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00812955
• Other Study ID Numbers: M10-667
• First Posted: Dec 22, 2008
• Last Update Posted: Oct 3, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by AstraZeneca: Dyslipidemia; Hypercholesterolemia; Hypertriglyceridemia
• Additional relevant MeSH terms: Hypercholesterolemia; Dyslipidemias; Hypertriglyceridemia; Simvastatin

Study Results

Participant Flow

Recruitment Details	474 subjects were randomized and treated at 111 sites in the United States between 29 December 2008 and 14 May 2009.

Arm/Group Title	Simvastatin Capsules 40 mg	ABT-143 Capsules 5/135 mg	ABT-143 Capsules 10/135 mg	ABT-143 Capsules 20/135 mg
Arm/Group Description	Simvastatin capsules 40 mg once daily for 8 weeks	ABT-143 capsules 5/135 mg once daily for 8 weeks	ABT-143 capsules 10/135 mg once daily for 8 weeks	ABT-143 capsules 20/135 mg once daily for 8 weeks
Period Title: Overall Study
STARTED	119	118	119	118
COMPLETED	109	111	113	110
NOT COMPLETED	10	7	6	8

Baseline Characteristics

Arm/Group Title	Simvastatin Capsules 40 mg	ABT-143 Capsules 5/135 mg	ABT-143 Capsules 10/135 mg	ABT-143 Capsules 20/135 mg	Total
Arm/Group Description	Simvastatin capsules 40 mg once daily for 8 weeks	ABT-143 capsules 5/135 mg once daily for 8 weeks	ABT-143 capsules 10/135 mg once daily for 8 weeks	ABT-143 capsules 20/135 mg once daily for 8 weeks	Total of all reporting groups
Overall Participants	119	118	119	118	474
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	92 77.3%	91 77.1%	95 79.8%	95 80.5%	373 78.7%
>=65 years	27 22.7%	27 22.9%	24 20.2%	23 19.5%	101 21.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.8 (9.77)	56.8 (8.91)	56.6 (9.27)	56.0 (10.41)	56.6 (9.58)
Sex: Female, Male (Count of Participants)
Female	71 59.7%	62 52.5%	59 49.6%	60 50.8%	252 53.2%
Male	48 40.3%	56 47.5%	60 50.4%	58 49.2%	222 46.8%
Region of Enrollment (participants) [Number]
United States	119 100%	118 100%	119 100%	118 100%	474 100%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
Description	The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

Arm/Group Title	Simvastatin Capsules 40 mg	ABT-143 Capsules 20/135 mg
Arm/Group Description	Simvastatin capsules 40 mg	ABT-143 capsules 20/135 mg
Measure Participants	114	113
Mean (Standard Error) [percent change]	-32.8 (1.59)	-47.2 (1.60)

2. Secondary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)
Description	The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

Arm/Group Title	Simvastatin Capsules 40 mg	ABT-143 Capsules 10/135 mg
Arm/Group Description	Simvastatin capsules 40 mg	ABT-143 capsules 10/135 mg
Measure Participants	114	115
Mean (Standard Error) [percent change]	-32.8 (1.59)	-46.0 (1.59)

3. Secondary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)
Description	The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

Arm/Group Title	Simvastatin Capsules 40 mg	ABT-143 Capsules 5/135 mg
Arm/Group Description	Simvastatin capsules 40 mg	ABT-143 capsules 5/135 mg
Measure Participants	114	114
Mean (Standard Error) [percent change]	-32.8 (1.59)	-38.9 (1.59)

4. Other Pre-specified Outcome

Title	Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)
Description	The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

Arm/Group Title	Simvastatin Capsules 40 mg	ABT-143 Capsules 5/135 mg	ABT-143 Capsules 10/135 mg	ABT-143 Capsules 20/135 mg
Arm/Group Description	Simvastatin capsules 40 mg once daily for 8 weeks	ABT-143 capsules 5/135 mg once daily for 8 weeks	ABT-143 capsules 10/135 mg once daily for 8 weeks	ABT-143 capsules 20/135 mg once daily for 8 weeks
Measure Participants	114	114	115	113
Median (Inter-Quartile Range) [percent change]	-20.8	-42.7	-44.6	-50.0

5. Other Pre-specified Outcome

Title	Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)
Description	The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.

Arm/Group Title	Simvastatin Capsules 40 mg	ABT-143 Capsules 5/135 mg	ABT-143 Capsules 10/135 mg	ABT-143 Capsules 20/135 mg
Arm/Group Description	Simvastatin capsules 40 mg once daily for 8 weeks	ABT-143 capsules 5/135 mg once daily for 8 weeks	ABT-143 capsules 10/135 mg once daily for 8 weeks	ABT-143 capsules 20/135 mg once daily for 8 weeks
Measure Participants	114	114	115	113
Mean (Standard Error) [percent change]	9.6 (1.56)	16.2 (1.56)	14.0 (1.55)	15.7 (1.56)

Adverse Events

Time Frame	18 weeks
Adverse Event Reporting Description	Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Serious adverse events were collected from the time the participant signed the informed consent until 30 calendar days following discontinuation of study drug.
Arm/Group Title	Simvastatin Capsules 40 mg		ABT-143 Capsules 5/135 mg		ABT-143 Capsules 10/135 mg		ABT-143 Capsules 20/135 mg
Arm/Group Description	Simvastatin capsules 40 mg once daily for 8 weeks		ABT-143 capsules 5/135 mg once daily for 8 weeks		ABT-143 capsules 10/135 mg once daily for 8 weeks		ABT-143 capsules 20/135 mg once daily for 8 weeks
All Cause Mortality
	Simvastatin Capsules 40 mg		ABT-143 Capsules 5/135 mg		ABT-143 Capsules 10/135 mg		ABT-143 Capsules 20/135 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Simvastatin Capsules 40 mg		ABT-143 Capsules 5/135 mg		ABT-143 Capsules 10/135 mg		ABT-143 Capsules 20/135 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		4/118 (3.4%)		1/119 (0.8%)		3/118 (2.5%)
Cardiac disorders
Angina Pectoris	0/119 (0%)		1/118 (0.8%)		0/119 (0%)		0/118 (0%)
Myocardial Infarction	0/119 (0%)		0/118 (0%)		0/119 (0%)		1/118 (0.8%)
Tachycardia	0/119 (0%)		1/118 (0.8%)		0/119 (0%)		0/118 (0%)
Gastrointestinal disorders
Abdominal Hernia	0/119 (0%)		0/118 (0%)		1/119 (0.8%)		0/118 (0%)
General disorders
Chest Pain	0/119 (0%)		0/118 (0%)		0/119 (0%)		1/118 (0.8%)
Investigations
Blood Creatine Phosphokinase Increased	0/119 (0%)		0/118 (0%)		0/119 (0%)		1/118 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer	0/119 (0%)		1/118 (0.8%)		0/119 (0%)		0/118 (0%)
Nervous system disorders
Syncope	0/119 (0%)		1/118 (0.8%)		0/119 (0%)		0/118 (0%)
Other (Not Including Serious) Adverse Events
	Simvastatin Capsules 40 mg		ABT-143 Capsules 5/135 mg		ABT-143 Capsules 10/135 mg		ABT-143 Capsules 20/135 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/119 (8.4%)		13/118 (11%)		6/119 (5%)		17/118 (14.4%)
Gastrointestinal disorders
Nausea	2/119 (1.7%)		7/118 (5.9%)		3/119 (2.5%)		6/118 (5.1%)
Infections and infestations
Upper Respiratory Tract Infection	1/119 (0.8%)		2/118 (1.7%)		2/119 (1.7%)		7/118 (5.9%)
Nervous system disorders
Headache	8/119 (6.7%)		5/118 (4.2%)		1/119 (0.8%)		7/118 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.