A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00463606
• Collaborator: (none)
• Enrollment: 760
• Locations: 168
• Arms: 3
• Duration (Months): 10.1
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia; Dyslipidemia	Drug: ABT-335 and rosuvastatin calcium; Drug: ABT-335; Drug: rosuvastatin calcium	Phase 3

Detailed Description

There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and mean percent change in LDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy. The 6 secondary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in Non-HDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy, mean percent change in Non-HDL-C, VLDL-C, ApoB, and Total Cholesterol comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and median percent change in hsCRP comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy).

Study Design

• Study Type: Interventional
• Actual Enrollment: 760 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-335 and Rosuvastatin Calcium ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks	Drug: ABT-335 and rosuvastatin calcium; ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks; Other Names: ABT-335 / Rosuvastatin Combination (ABT-143)
Active Comparator: ABT-335 ABT-335 135mg monotherapy administered orally, once daily for 12 weeks	Drug: ABT-335; ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks; Other Names: fenofibric acid
Active Comparator: Rosuvastatin Calcium Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks	Drug: rosuvastatin calcium; Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks; Other Names: Rosuvastatin

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) [Baseline to 12 Weeks]

   The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

2. Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) [Baseline to 12 Weeks]

   The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

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

   The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.

Secondary Outcome Measures

1. Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) [Baseline to 12 Weeks]

   The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.

2. Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) [Baseline to 12 Weeks]

   The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

3. Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set) [Baseline to 12 Weeks]

   The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

4. Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set) [Baseline to 12 Weeks]

   The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

5. Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set) [Baseline to 12 Weeks]

   The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

6. Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set) [Baseline to 12 Weeks]

   The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Eligibility Criteria

Criteria

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

Inclusion Criteria

• Adult male and female participants who voluntarily sign the informed consent.

• Fasting lipid results following greater than 12-hour fasting period:

• Triglycerides level greater than or equal to 150 mg/dL,

• High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and

• Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL.

• Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.

Exclusion Criteria

• Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study.

• Participants receiving coumarin anticoagulants or systemic cyclosporine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 5469	Birmingham	Alabama	United States	35205
2	Site Reference ID/Investigator# 4428	Birmingham	Alabama	United States	35209-6802
3	Site Reference ID/Investigator# 4985	Birmingham	Alabama	United States	35235
4	Site Reference ID/Investigator# 4493	Huntsville	Alabama	United States	35801
5	Site Reference ID/Investigator# 4510	Huntsville	Alabama	United States	35802
6	Site Reference ID/Investigator# 4431	Ozark	Alabama	United States	36360
7	Site Reference ID/Investigator# 4519	Tuscaloosa	Alabama	United States	35406
8	Site Reference ID/Investigator# 4395	Chandler	Arizona	United States	85225
9	Site Reference ID/Investigator# 4483	Gilbert	Arizona	United States	85295
10	Site Reference ID/Investigator# 4411	Scottsdale	Arizona	United States	85251
11	Site Reference ID/Investigator# 4417	Little Rock	Arkansas	United States	72204
12	Site Reference ID/Investigator# 4702	Anaheim	California	United States	92804
13	Site Reference ID/Investigator# 5593	Chula Vista	California	United States	91911
14	Site Reference ID/Investigator# 4503	Concord	California	United States	94520
15	Site Reference ID/Investigator# 4530	Encinitas	California	United States	92024
16	Site Reference ID/Investigator# 4458	Fair Oaks	California	United States	95628
17	Site Reference ID/Investigator# 4542	Fresno	California	United States	93703
18	Site Reference ID/Investigator# 4574	Fresno	California	United States	93710
19	Site Reference ID/Investigator# 4441	Lincoln	California	United States	95648
20	Site Reference ID/Investigator# 4432	Long Beach	California	United States	90806
21	Site Reference ID/Investigator# 5579	Los Angeles	California	United States	90057
22	Site Reference ID/Investigator# 4980	Norwalk	California	United States	90650
23	Site Reference ID/Investigator# 4392	Sacramento	California	United States	95825
24	Site Reference ID/Investigator# 4896	Sacramento	California	United States	95825
25	Site Reference ID/Investigator# 5582	San Diego	California	United States	92128
26	Site Reference ID/Investigator# 6236	West Hills	California	United States	91307
27	Site Reference ID/Investigator# 4442	Aurora	Colorado	United States	80012
28	Site Reference ID/Investigator# 4419	Colorado Springs	Colorado	United States	80909
29	Site Reference ID/Investigator# 4391	Waterbury	Connecticut	United States	06708
30	Site Reference ID/Investigator# 4401	Coral Gables	Florida	United States	33134
31	Site Reference ID/Investigator# 4453	Fort Lauderdale	Florida	United States	33308
32	Site Reference ID/Investigator# 4490	Holly Hill	Florida	United States	32117
33	Site Reference ID/Investigator# 4420	Hollywood	Florida	United States	33021
34	Site Reference ID/Investigator# 5011	Jacksonville	Florida	United States	32216
35	Site Reference ID/Investigator# 4444	Jacksonville	Florida	United States	32259
36	Site Reference ID/Investigator# 4399	Jupiter	Florida	United States	33458-7200
37	Site Reference ID/Investigator# 4433	Kissimmee	Florida	United States	34741
38	Site Reference ID/Investigator# 4469	Largo	Florida	United States	33773
39	Site Reference ID/Investigator# 4525	Melbourne	Florida	United States	32935
40	Site Reference ID/Investigator# 4477	Miami	Florida	United States	33173
41	Site Reference ID/Investigator# 4430	New Port Richey	Florida	United States	34652
42	Site Reference ID/Investigator# 4409	New Smyrna Beach	Florida	United States	32168
43	Site Reference ID/Investigator# 4416	Ocala	Florida	United States	34471
44	Site Reference ID/Investigator# 4528	Ocala	Florida	United States	34471
45	Site Reference ID/Investigator# 5103	Orlando	Florida	United States	32806
46	Site Reference ID/Investigator# 4446	Ormond Beach	Florida	United States	32174
47	Site Reference ID/Investigator# 4524	Pensacola	Florida	United States	32514
48	Site Reference ID/Investigator# 4505	Sarasota	Florida	United States	34233
49	Site Reference ID/Investigator# 5580	Sarasota	Florida	United States	34239
50	Site Reference ID/Investigator# 4494	West Palm Beach	Florida	United States	33401
51	Site Reference ID/Investigator# 4407	West Palm Beach	Florida	United States	33407
52	Site Reference ID/Investigator# 4512	Winter Haven	Florida	United States	33880
53	Site Reference ID/Investigator# 5478	Blue Ridge	Georgia	United States	30513
54	Site Reference ID/Investigator# 4388	Decatur	Georgia	United States	30033
55	Site Reference ID/Investigator# 4511	Dunwoody	Georgia	United States	30338
56	Site Reference ID/Investigator# 4981	Roswell	Georgia	United States	30075
57	Site Reference ID/Investigator# 4448	Roswell	Georgia	United States	30076
58	Site Reference ID/Investigator# 4497	Suwanee	Georgia	United States	30024
59	Site Reference ID/Investigator# 4439	Woodstock	Georgia	United States	30189
60	Site Reference ID/Investigator# 4472	Arlington Heights	Illinois	United States	60004
61	Site Reference ID/Investigator# 5585	Chicago	Illinois	United States	60654
62	Site Reference ID/Investigator# 4520	Peoria	Illinois	United States	61602
63	Site Reference ID/Investigator# 4527	Avon	Indiana	United States	46123
64	Site Reference ID/Investigator# 4485	Evansville	Indiana	United States	47714
65	Site Reference ID/Investigator# 4445	Indianapolis	Indiana	United States	46260
66	Site Reference ID/Investigator# 4438	Lafayette	Indiana	United States	47904
67	Site Reference ID/Investigator# 5010	Newburgh	Indiana	United States	47630
68	Site Reference ID/Investigator# 4403	Iowa City	Iowa	United States	52242
69	Site Reference ID/Investigator# 4393	Arkansas City	Kansas	United States	67005
70	Site Reference ID/Investigator# 4526	Overland Park	Kansas	United States	66202
71	Site Reference ID/Investigator# 4423	Wichita	Kansas	United States	67203
72	Site Reference ID/Investigator# 4424	Wichita	Kansas	United States	67207
73	Site Reference ID/Investigator# 5027	Lexington	Kentucky	United States	40509
74	Site Reference ID/Investigator# 4471	Louisville	Kentucky	United States	40213
75	Site Reference ID/Investigator# 4406	New Orleans	Louisiana	United States	70112
76	Site Reference ID/Investigator# 4509	Slidell	Louisiana	United States	70458
77	Site Reference ID/Investigator# 5635	Auburn	Maine	United States	04210
78	Site Reference ID/Investigator# 4502	Scarborough	Maine	United States	04074
79	Site Reference ID/Investigator# 5070	Baltimore	Maryland	United States	21209
80	Site Reference ID/Investigator# 4412	Haverhill	Massachusetts	United States	01830
81	Site Reference ID/Investigator# 4487	Springfield	Massachusetts	United States	01103
82	Site Reference ID/Investigator# 5533	Ann Arbor	Michigan	United States	48106
83	Site Reference ID/Investigator# 6237	Ann Arbor	Michigan	United States	48106
84	Site Reference ID/Investigator# 5583	Portage	Michigan	United States	49024
85	Site Reference ID/Investigator# 4480	Brooklyn Center	Minnesota	United States	55430
86	Site Reference ID/Investigator# 4515	Jackson	Mississippi	United States	39202
87	Site Reference ID/Investigator# 4492	Olive Branch	Mississippi	United States	38654
88	Site Reference ID/Investigator# 5636	Tupelo	Mississippi	United States	38801
89	Site Reference ID/Investigator# 4500	Kansas City	Missouri	United States	64114
90	Site Reference ID/Investigator# 4499	St. Peters	Missouri	United States	63376
91	Site Reference ID/Investigator# 4979	Billings	Montana	United States	59101
92	Site Reference ID/Investigator# 4481	Missoula	Montana	United States	59808
93	Site Reference ID/Investigator# 4460	Las Vegas	Nevada	United States	89102
94	Site Reference ID/Investigator# 4466	Las Vegas	Nevada	United States	89123
95	Site Reference ID/Investigator# 5484	Las Vegas	Nevada	United States	89146
96	Site Reference ID/Investigator# 5444	Concord	New Hampshire	United States	03301
97	Site Reference ID/Investigator# 4908	Elizabeth	New Jersey	United States	07202
98	Site Reference ID/Investigator# 4504	South Bound Brook	New Jersey	United States	08880
99	Site Reference ID/Investigator# 4394	Toms River	New Jersey	United States	08755
100	Site Reference ID/Investigator# 4402	Trenton	New Jersey	United States	08611
101	Site Reference ID/Investigator# 4427	Albuquerque	New Mexico	United States	87108
102	Site Reference ID/Investigator# 4463	Bronxville	New York	United States	10708
103	Site Reference ID/Investigator# 4415	New York	New York	United States	10021
104	Site Reference ID/Investigator# 4440	Rochester	New York	United States	14609
105	Site Reference ID/Investigator# 4464	Syracuse	New York	United States	13202
106	Site Reference ID/Investigator# 4425	Williamsville	New York	United States	14221
107	Site Reference ID/Investigator# 4473	Asheville	North Carolina	United States	28803
108	Site Reference ID/Investigator# 4531	Charlotte	North Carolina	United States	28209
109	Site Reference ID/Investigator# 4396	Charlotte	North Carolina	United States	28277
110	Site Reference ID/Investigator# 5494	Hickory	North Carolina	United States	28601
111	Site Reference ID/Investigator# 4479	Morehead City	North Carolina	United States	28557
112	Site Reference ID/Investigator# 4461	Raleigh	North Carolina	United States	27609
113	Site Reference ID/Investigator# 4498	Salisbury	North Carolina	United States	28144
114	Site Reference ID/Investigator# 4405	Statesville	North Carolina	United States	28677
115	Site Reference ID/Investigator# 4476	Winston-Salem	North Carolina	United States	27103
116	Site Reference ID/Investigator# 4390	Cincinnati	Ohio	United States	45212
117	Site Reference ID/Investigator# 4400	Cincinnati	Ohio	United States	45219
118	Site Reference ID/Investigator# 4501	Cincinnati	Ohio	United States	45219
119	Site Reference ID/Investigator# 4517	Cincinnati	Ohio	United States	45246
120	Site Reference ID/Investigator# 5584	Columbus	Ohio	United States	43212
121	Site Reference ID/Investigator# 4410	Mogadore	Ohio	United States	44260
122	Site Reference ID/Investigator# 4443	Sandusky	Ohio	United States	44870
123	Site Reference ID/Investigator# 4523	Warren	Ohio	United States	44483
124	Site Reference ID/Investigator# 4488	Oklahoma City	Oklahoma	United States	73103
125	Site Reference ID/Investigator# 4451	Oklahoma City	Oklahoma	United States	73112
126	Site Reference ID/Investigator# 4422	Tulsa	Oklahoma	United States	74104
127	Site Reference ID/Investigator# 4482	Tulsa	Oklahoma	United States	74136
128	Site Reference ID/Investigator# 4467	Medford	Oregon	United States	97504
129	Site Reference ID/Investigator# 4470	Carlisle	Pennsylvania	United States	17015
130	Site Reference ID/Investigator# 5581	Downingtown	Pennsylvania	United States	19335
131	Site Reference ID/Investigator# 4434	Feasterville	Pennsylvania	United States	19053
132	Site Reference ID/Investigator# 4478	Harleysville	Pennsylvania	United States	19438-2513
133	Site Reference ID/Investigator# 4436	Jersey Shore	Pennsylvania	United States	17740
134	Site Reference ID/Investigator# 4397	Lansdale	Pennsylvania	United States	19046
135	Site Reference ID/Investigator# 4426	Melrose Park	Pennsylvania	United States	19027
136	Site Reference ID/Investigator# 4894	Newtown	Pennsylvania	United States	18940
137	Site Reference ID/Investigator# 4496	Penndel	Pennsylvania	United States	19047
138	Site Reference ID/Investigator# 4404	Philadelphia	Pennsylvania	United States	19114
139	Site Reference ID/Investigator# 4437	Philadelphia	Pennsylvania	United States	19115
140	Site Reference ID/Investigator# 4387	Philadelphia	Pennsylvania	United States	19152
141	Site Reference ID/Investigator# 4447	Warminster	Pennsylvania	United States	18974
142	Site Reference ID/Investigator# 4506	Charleston	South Carolina	United States	29407
143	Site Reference ID/Investigator# 5443	Greenville	South Carolina	United States	29615
144	Site Reference ID/Investigator# 4484	Greer	South Carolina	United States	29651
145	Site Reference ID/Investigator# 4455	Moncks Corner	South Carolina	United States	29461
146	Site Reference ID/Investigator# 4513	Mount Pleasant	South Carolina	United States	29464
147	Site Reference ID/Investigator# 4521	Simpsonville	South Carolina	United States	29681
148	Site Reference ID/Investigator# 4982	Summerville	South Carolina	United States	29485
149	Site Reference ID/Investigator# 5586	Sioux Falls	South Dakota	United States	57104
150	Site Reference ID/Investigator# 4435	Jackson	Tennessee	United States	38305
151	Site Reference ID/Investigator# 4454	Johnson City	Tennessee	United States	37601
152	Site Reference ID/Investigator# 4529	Nashville	Tennessee	United States	37205
153	Site Reference ID/Investigator# 5454	Arlington	Texas	United States	76012
154	Site Reference ID/Investigator# 5578	Houston	Texas	United States	77030
155	Site Reference ID/Investigator# 5669	Houston	Texas	United States	77030
156	Site Reference ID/Investigator# 4893	San Antonio	Texas	United States	78205
157	Site Reference ID/Investigator# 4429	San Antonio	Texas	United States	78215
158	Site Reference ID/Investigator# 4457	San Antonio	Texas	United States	78224
159	Site Reference ID/Investigator# 4465	San Antonio	Texas	United States	78229-4801
160	Site Reference ID/Investigator# 4508	San Antonio	Texas	United States	78229
161	Site Reference ID/Investigator# 4892	San Antonio	Texas	United States	78229
162	Site Reference ID/Investigator# 5948	San Antonio	Texas	United States	78229
163	Site Reference ID/Investigator# 4413	Temple	Texas	United States	76502
164	Site Reference ID/Investigator# 4456	Falls Church	Virginia	United States	22044
165	Site Reference ID/Investigator# 4459	Richmond	Virginia	United States	23226
166	Site Reference ID/Investigator# 4408	Richmond	Virginia	United States	23294
167	Site Reference ID/Investigator# 4421	Lakewood	Washington	United States	98499
168	Site Reference ID/Investigator# 4468	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: NCT00463606
• Other Study ID Numbers: M06-844
• First Posted: Apr 20, 2007
• Last Update Posted: Oct 3, 2012
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Hypercholesterolemia; Dyslipidemias; Calcium, Dietary; Rosuvastatin Calcium; Fenofibric acid; Calcium

Study Results

Participant Flow

Recruitment Details	760 participants were randomized at 144 sites in the United States, and 758 participants were treated between 07 June 2007 and 10 February 2008. Two participants were randomized but not treated: 1 was lost to follow-up and 1 was withdrawn at the investigator's discretion.
Pre-assignment Detail	A total of 168 study sites screened participants, wtih 144 of these sites randomizing participants.

Arm/Group Title	ABT-335 and Rosuvastatin Calcium	ABT-335	Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Period Title: Overall Study
STARTED	253	254	251
COMPLETED	212	220	231
NOT COMPLETED	41	34	20

Baseline Characteristics

Arm/Group Title	ABT-335 and Rosuvastatin Calcium	ABT-335	Rosuvastatin Calcium	Total
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks	Total of all reporting groups
Overall Participants	253	254	251	758
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	194 76.7%	203 79.9%	205 81.7%	602 79.4%
>=65 years	59 23.3%	51 20.1%	46 18.3%	156 20.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.2 (11.30)	54.4 (11.24)	55.3 (10.71)	55.3 (11.10)
Sex: Female, Male (Count of Participants)
Female	161 63.6%	144 56.7%	150 59.8%	455 60%
Male	92 36.4%	110 43.3%	101 40.2%	303 40%
Region of Enrollment (participants) [Number]
United States	253 100%	254 100%	251 100%	758 100%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)
Description	The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was defined as all randomized participants who had both a baseline and at least 1 post-baseline value for high-density lipoprotein cholesterol. 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	ABT-335 and Rosuvastatin Calcium	Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	236	241
Mean (Standard Error) [percent change]	23.0 (1.33)	12.4 (1.32)

2. Primary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)
Description	The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was 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	ABT-335 and Rosuvastatin Calcium	Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	236	241
Mean (Standard Error) [percent change]	-40.3 (1.89)	-17.5 (1.88)

3. 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 (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for low-density lipoprotein cholesterol. 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	ABT-335 and Rosuvastatin Calcium	ABT-335
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	236	245
Mean (Standard Error) [percent change]	-28.7 (1.33)	-4.1 (1.31)

4. Secondary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)
Description	The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-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	ABT-335 and Rosuvastatin Calcium	ABT-335
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	236	245
Mean (Standard Error) [percent change]	-37.4 (1.06)	-16.0 (1.05)

5. Secondary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)
Description	The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-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	ABT-335 and Rosuvastatin Calcium	Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	236	241
Mean (Standard Error) [percent change]	-37.4 (1.06)	-31.8 (1.05)

6. Secondary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)
Description	The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for VLDL-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	ABT-335 and Rosuvastatin Calcium	Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	235	239
Mean (Standard Error) [percent change]	-41.3 (3.56)	-22.2 (3.53)

7. Secondary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)
Description	The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for ApoB. 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	ABT-335 and Rosuvastatin Calcium	Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	233	238
Mean (Standard Error) [percent change]	-30.9 (1.00)	-26.4 (0.99)

8. Secondary Outcome

Title	Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)
Description	The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for hsCRP. 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	ABT-335 and Rosuvastatin Calcium	Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	235	240
Median (Inter-Quartile Range) [percent change]	-28.0	-11.4

9. Secondary Outcome

Title	Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)
Description	The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame	Baseline to 12 Weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for total cholesterol. 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	ABT-335 and Rosuvastatin Calcium	Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks	Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Measure Participants	236	241
Mean (Standard Error) [percent change]	-28.1 (0.85)	-25.0 (0.84)

Adverse Events

Time Frame	Up to 23 weeks
Adverse Event Reporting Description	All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Arm/Group Title	ABT-335 and Rosuvastatin Calcium		ABT-335		Rosuvastatin Calcium
Arm/Group Description	ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks		ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks		Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
All Cause Mortality
	ABT-335 and Rosuvastatin Calcium		ABT-335		Rosuvastatin Calcium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ABT-335 and Rosuvastatin Calcium		ABT-335		Rosuvastatin Calcium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/253 (2.8%)		6/254 (2.4%)		4/251 (1.6%)
Cardiac disorders
Acute myocardial infarction	0/253 (0%)		0/254 (0%)		1/251 (0.4%)
Cardiogenic shock	0/253 (0%)		0/254 (0%)		1/251 (0.4%)
Coronary artery disease	2/253 (0.8%)		1/254 (0.4%)		0/251 (0%)
Myocardial infarction	1/253 (0.4%)		0/254 (0%)		0/251 (0%)
Gastrointestinal disorders
Pancreatitis acute	0/253 (0%)		0/254 (0%)		1/251 (0.4%)
General disorders
Chest pain	1/253 (0.4%)		0/254 (0%)		0/251 (0%)
Cyst	0/253 (0%)		1/254 (0.4%)		0/251 (0%)
Infections and infestations
Bronchitis	0/253 (0%)		1/254 (0.4%)		0/251 (0%)
Musculoskeletal and connective tissue disorders
Rhabdomyolysis	1/253 (0.4%)		0/254 (0%)		0/251 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma	1/253 (0.4%)		0/254 (0%)		0/251 (0%)
Pituitary tumour benign	0/253 (0%)		1/254 (0.4%)		0/251 (0%)
Renal cell carcinoma stage unspecified	0/253 (0%)		0/254 (0%)		1/251 (0.4%)
Nervous system disorders
Aphasia	0/253 (0%)		1/254 (0.4%)		0/251 (0%)
Cerebrovascular accident	0/253 (0%)		1/254 (0.4%)		0/251 (0%)
Haemorrhage intracranial	1/253 (0.4%)		0/254 (0%)		0/251 (0%)
Transient ischaemic attack	1/253 (0.4%)		0/254 (0%)		0/251 (0%)
Psychiatric disorders
Anxiety	0/253 (0%)		0/254 (0%)		1/251 (0.4%)
Mental status changes	0/253 (0%)		1/254 (0.4%)		0/251 (0%)
Renal and urinary disorders
Nephrolithiasis	0/253 (0%)		0/254 (0%)		1/251 (0.4%)
Reproductive system and breast disorders
Uterovaginal prolapse	0/253 (0%)		0/254 (0%)		1/251 (0.4%)
Other (Not Including Serious) Adverse Events
	ABT-335 and Rosuvastatin Calcium		ABT-335		Rosuvastatin Calcium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/253 (20.6%)		41/254 (16.1%)		45/251 (17.9%)
Gastrointestinal disorders
Dyspepsia	16/253 (6.3%)		6/254 (2.4%)		2/251 (0.8%)
Infections and infestations
Nasopharyngitis	6/253 (2.4%)		15/254 (5.9%)		8/251 (3.2%)
Musculoskeletal and connective tissue disorders
Back pain	11/253 (4.3%)		11/254 (4.3%)		14/251 (5.6%)
Nervous system disorders
Headache	28/253 (11.1%)		23/254 (9.1%)		32/251 (12.7%)

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.