30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00680017
• Collaborator: (none)
• Enrollment: 280
• Locations: 114
• Arms: 2
• Duration (Months): 34
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia; Kidney Disease	Drug: ABT-335 plus rosuvastatin; Drug: Rosuvastatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-335 plus rosuvastatin ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks	Drug: ABT-335 plus rosuvastatin; ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks; Other Names: fenofibric acid and rosuvastatin
Active Comparator: Rosuvastatin Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks	Drug: Rosuvastatin; Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks; Other Names: rosuvastatin, Crestor

Outcome Measures

Primary Outcome Measures

1. Median Percent Change in Triglycerides From Baseline to Week 8. [Baseline to 8 weeks]

   Triglycerides were measured in milligrams/deciliter.

Secondary Outcome Measures

1. Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8. [Baseline to 8 weeks]

   High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).

Eligibility Criteria

Criteria

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

Inclusion Criteria

• Dyslipidemic participants with Chronic Kidney Disease Stage 3

• For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit[s]):

• Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay).

• Fasting lipid results following greater than or equal to 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 Exclusion Criteria

• Participants with certain chronic or unstable medical conditions.

• Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications.

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

• Participants with diabetes mellitus that is poorly controlled.

• Participants 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# 22521	Birmingham	Alabama	United States	35242
2	Site Reference ID/Investigator# 22478	Huntsville	Alabama	United States	35801
3	Site Reference ID/Investigator# 8365	Madison	Alabama	United States	35758
4	Site Reference ID/Investigator# 8416	Montgomery	Alabama	United States	36106-1111
5	Site Reference ID/Investigator# 7869	Chula Vista	California	United States	91910
6	Site Reference ID/Investigator# 8435	Fountain Valley	California	United States	92708
7	Site Reference ID/Investigator# 22487	Lincoln	California	United States	95648
8	Site Reference ID/Investigator# 22426	Long Beach	California	United States	90806
9	Site Reference ID/Investigator# 8096	Los Angeles	California	United States	90048
10	Site Reference ID/Investigator# 22962	Norwalk	California	United States	90650
11	Site Reference ID/Investigator# 8311	Riverside	California	United States	92505
12	Site Reference ID/Investigator# 22816	Sacramento	California	United States	95825
13	Site Reference ID/Investigator# 8510	Simi Valley	California	United States	93065
14	Site Reference ID/Investigator# 22821	West Hills	California	United States	91307
15	Site Reference ID/Investigator# 7958	Arvada	Colorado	United States	80002
16	Site Reference ID/Investigator# 15881	Denver	Colorado	United States	80230
17	Site Reference ID/Investigator# 8399	Westminster	Colorado	United States	80031
18	Site Reference ID/Investigator# 23224	Boynton Beach	Florida	United States	33472
19	Site Reference ID/Investigator# 22474	Clearwater	Florida	United States	33756
20	Site Reference ID/Investigator# 21803	Coral Springs	Florida	United States	33065
21	Site Reference ID/Investigator# 22811	Daytona Beach	Florida	United States	32117
22	Site Reference ID/Investigator# 27103	Hollywood	Florida	United States	33021
23	Site Reference ID/Investigator# 8398	Hudson	Florida	United States	34667
24	Site Reference ID/Investigator# 26723	Kissimmee	Florida	United States	34741
25	Site Reference ID/Investigator# 37676	Kissimmee	Florida	United States	34759
26	Site Reference ID/Investigator# 8231	Lauderdale Lakes	Florida	United States	33313
27	Site Reference ID/Investigator# 22486	Longwood	Florida	United States	32779
28	Site Reference ID/Investigator# 22520	New Port Richey	Florida	United States	34652
29	Site Reference ID/Investigator# 8226	Orlando	Florida	United States	32804
30	Site Reference ID/Investigator# 22477	Ormond Beach	Florida	United States	32174
31	Site Reference ID/Investigator# 8386	Pembroke Pines	Florida	United States	33028
32	Site Reference ID/Investigator# 22518	Plant City	Florida	United States	33563
33	Site Reference ID/Investigator# 12882	Port Charlotte	Florida	United States	33952
34	Site Reference ID/Investigator# 37675	St. Cloud	Florida	United States	34769
35	Site Reference ID/Investigator# 8410	West Palm Beach	Florida	United States	33401
36	Site Reference ID/Investigator# 21802	Winter Haven	Florida	United States	33880
37	Site Reference ID/Investigator# 8136	Atlanta	Georgia	United States	30331
38	Site Reference ID/Investigator# 23503	Dunwoody	Georgia	United States	30338
39	Site Reference ID/Investigator# 7948	Macon	Georgia	United States	31217
40	Site Reference ID/Investigator# 22819	Roswell	Georgia	United States	30076
41	Site Reference ID/Investigator# 22813	Suwanee	Georgia	United States	30024
42	Site Reference ID/Investigator# 27682	Chicago	Illinois	United States	60616
43	Site Reference ID/Investigator# 8227	Peoria	Illinois	United States	61603
44	Site Reference ID/Investigator# 13922	Mishawaka	Indiana	United States	46545-3519
45	Site Reference ID/Investigator# 8094	Council Bluffs	Iowa	United States	51501
46	Site Reference ID/Investigator# 22430	Iowa City	Iowa	United States	52242
47	Site Reference ID/Investigator# 8093	Paducah	Kentucky	United States	42003
48	Site Reference ID/Investigator# 38405	Baton Rouge	Louisiana	United States	70809
49	Site Reference ID/Investigator# 8903	Shreveport	Louisiana	United States	71101
50	Site Reference ID/Investigator# 21805	Auburn	Maine	United States	04210
51	Site Reference ID/Investigator# 8092	Rockville	Maryland	United States	20852
52	Site Reference ID/Investigator# 8225	Fall River	Massachusetts	United States	02720
53	Site Reference ID/Investigator# 8407	Springfield	Massachusetts	United States	01107
54	Site Reference ID/Investigator# 8415	Royal Oak	Michigan	United States	48073
55	Site Reference ID/Investigator# 22222	Brooklyn Center	Minnesota	United States	55430
56	Site Reference ID/Investigator# 8408	Olive Branch	Mississippi	United States	38654
57	Site Reference ID/Investigator# 22703	Berlin	New Jersey	United States	08009
58	Site Reference ID/Investigator# 22707	Elizabeth	New Jersey	United States	07202
59	Site Reference ID/Investigator# 22702	Hillsborough	New Jersey	United States	08844
60	Site Reference ID/Investigator# 8387	Flushing	New York	United States	11355
61	Site Reference ID/Investigator# 8177	Great Neck	New York	United States	11021
62	Site Reference ID/Investigator# 8146	Lake Success	New York	United States	11042
63	Site Reference ID/Investigator# 22427	Williamsville	New York	United States	14221
64	Site Reference ID/Investigator# 22481	Charlotte	North Carolina	United States	28262
65	Site Reference ID/Investigator# 22708	Charlotte	North Carolina	United States	28277
66	Site Reference ID/Investigator# 8434	Morehead City	North Carolina	United States	28557
67	Site Reference ID/Investigator# 8417	Cincinnati	Ohio	United States	45267-0585
68	Site Reference ID/Investigator# 8147	Columbus	Ohio	United States	43215
69	Site Reference ID/Investigator# 22488	Mason	Ohio	United States	45040
70	Site Reference ID/Investigator# 22479	Oklahoma City	Oklahoma	United States	73103
71	Site Reference ID/Investigator# 23225	Oklahoma City	Oklahoma	United States	73112
72	Site Reference ID/Investigator# 22482	Tulsa	Oklahoma	United States	74136
73	Site Reference ID/Investigator# 8345	Bend	Oregon	United States	97701
74	Site Reference ID/Investigator# 22704	Medford	Oregon	United States	97504
75	Site Reference ID/Investigator# 8400	Portland	Oregon	United States	97210
76	Site Reference ID/Investigator# 8411	Bethlehem	Pennsylvania	United States	18017
77	Site Reference ID/Investigator# 8405	Carlisle	Pennsylvania	United States	17015
78	Site Reference ID/Investigator# 22387	Duncansville	Pennsylvania	United States	16635
79	Site Reference ID/Investigator# 22815	Jersey Shore	Pennsylvania	United States	17740
80	Site Reference ID/Investigator# 12881	Johnstown	Pennsylvania	United States	15905
81	Site Reference ID/Investigator# 22706	Perkasie	Pennsylvania	United States	18944
82	Site Reference ID/Investigator# 8095	Philadelphia	Pennsylvania	United States	19107
83	Site Reference ID/Investigator# 22705	Tipton	Pennsylvania	United States	16684
84	Site Reference ID/Investigator# 22817	Warminster	Pennsylvania	United States	18974
85	Site Reference ID/Investigator# 8098	Providence	Rhode Island	United States	02904
86	Site Reference ID/Investigator# 22823	Charleston	South Carolina	United States	29412
87	Site Reference ID/Investigator# 8364	Columbia	South Carolina	United States	29206
88	Site Reference ID/Investigator# 22429	Greenville	South Carolina	United States	29605
89	Site Reference ID/Investigator# 22428	Mount Pleasant	South Carolina	United States	29464
90	Site Reference ID/Investigator# 25302	Summerville	South Carolina	United States	29485
91	Site Reference ID/Investigator# 22812	Dallas	Texas	United States	75251
92	Site Reference ID/Investigator# 8536	Edinburg	Texas	United States	78539
93	Site Reference ID/Investigator# 22810	Fort Worth	Texas	United States	76104
94	Site Reference ID/Investigator# 24742	Houston	Texas	United States	77005
95	Site Reference ID/Investigator# 26722	Houston	Texas	United States	77024
96	Site Reference ID/Investigator# 8406	Houston	Texas	United States	77099
97	Site Reference ID/Investigator# 8232	Lubbock	Texas	United States	79410
98	Site Reference ID/Investigator# 22480	San Antonio	Texas	United States	78224
99	Site Reference ID/Investigator# 8397	San Antonio	Texas	United States	78229
100	Site Reference ID/Investigator# 21804	Ogden	Utah	United States	84403
101	Site Reference ID/Investigator# 22423	Salt Lake City	Utah	United States	84124
102	Site Reference ID/Investigator# 8413	Gig Harbor	Washington	United States	98335
103	Site Reference ID/Investigator# 24402	Carolina		Puerto Rico	00983
104	Site Reference ID/Investigator# 22545	Humacao		Puerto Rico	00791
105	Site Reference ID/Investigator# 8301	Manati		Puerto Rico	00674
106	Site Reference ID/Investigator# 8299	Ponce		Puerto Rico	00717-0634
107	Site Reference ID/Investigator# 8418	Ponce		Puerto Rico	00717-1322
108	Site Reference ID/Investigator# 8419	Ponce		Puerto Rico	00717-2075
109	Site Reference ID/Investigator# 8421	San Juan		Puerto Rico	00907
110	Site Reference ID/Investigator# 8300	San Juan		Puerto Rico	00909
111	Site Reference ID/Investigator# 8422	San Juan		Puerto Rico	00918
112	Site Reference ID/Investigator# 8423	San Juan		Puerto Rico	00936-5067
113	Site Reference ID/Investigator# 8420	Toa Baja		Puerto Rico	00949
114	Site Reference ID/Investigator# 8298	Yabucoa		Puerto Rico	00767

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: NCT00680017
• Other Study ID Numbers: M10-313
• First Posted: May 19, 2008
• Last Update Posted: Oct 3, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by AstraZeneca: Dyslipidemia; Kidney Disease
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Dyslipidemias; Rosuvastatin Calcium; Fenofibric acid

Study Results

Participant Flow

Recruitment Details	280 participants were randomized and treated at 84 sites in the United States and Puerto Rico between 23 July 2008 and 02 March 2011.

Arm/Group Title	ABT-335 Plus Rosuvastatin	Rosuvastatin
Arm/Group Description	ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks	Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Period Title: Overall Study
STARTED	140	140
COMPLETED	123	128
NOT COMPLETED	17	12

Baseline Characteristics

Arm/Group Title	ABT-335 Plus Rosuvastatin	Rosuvastatin	Total
Arm/Group Description	ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks	Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks	Total of all reporting groups
Overall Participants	140	140	280
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	67 47.9%	48 34.3%	115 41.1%
>=65 years	73 52.1%	92 65.7%	165 58.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.1 (10.35)	67.4 (11.15)	66.2 (10.80)
Sex: Female, Male (Count of Participants)
Female	78 55.7%	71 50.7%	149 53.2%
Male	62 44.3%	69 49.3%	131 46.8%
Region of Enrollment (participants) [Number]
United States	129 92.1%	132 94.3%	261 93.2%
Puerto Rico	11 7.9%	8 5.7%	19 6.8%

Outcome Measures

1. Primary Outcome

Title	Median Percent Change in Triglycerides From Baseline to Week 8.
Description	Triglycerides were measured in milligrams/deciliter.
Time Frame	Baseline to 8 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 postbaseline 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 Plus Rosuvastatin	Rosuvastatin
Arm/Group Description	ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks	Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Measure Participants	137	138
Median (Inter-Quartile Range) [percent change]	-38.0	-22.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-335 Plus Rosuvastatin, Rosuvastatin
	Comments	The null hypothesis was that percent change in triglycerides (TG) from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in TG from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 98% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in TG.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as "statistically significant". No adjustments made for multiple comparisons since only 1 primary efficacy endpoint comparison.
	Method	Wilcoxon rank-sum test
	Comments

2. Secondary Outcome

Title	Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.
Description	High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).
Time Frame	Baseline to 8 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 postbaseline 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	ABT-335 Plus Rosuvastatin	Rosuvastatin
Arm/Group Description	ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks	Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Measure Participants	137	138
Least Squares Mean (Standard Error) [percent change]	16.9 (1.44)	7.8 (1.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-335 Plus Rosuvastatin, Rosuvastatin
	Comments	The null hypothesis was that percent change in HDL-C from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in HDL-C from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 82% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in HDL-C.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as "statistically significant". No adjustments made for multiple comparisons since only 1 secondary endpoint comparison.
	Method	ANCOVA
	Comments	P-value obtained from an ANCOVA with corresponding baseline value as the covariate and an effect for treatment group.

Adverse Events

Time Frame	24 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. Treatment-emergent 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	ABT-335 Plus Rosuvastatin		Rosuvastatin
Arm/Group Description	ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks		Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
All Cause Mortality
	ABT-335 Plus Rosuvastatin		Rosuvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ABT-335 Plus Rosuvastatin		Rosuvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/140 (6.4%)		11/140 (7.9%)
Cardiac disorders
Acute Coronary Syndrome	1/140 (0.7%)		0/140 (0%)
Acute Myocardial Infarction	1/140 (0.7%)		0/140 (0%)
Angina Unstable	0/140 (0%)		1/140 (0.7%)
Coronary Artery Disease	0/140 (0%)		3/140 (2.1%)
Myocardial Infarction	0/140 (0%)		2/140 (1.4%)
Gastrointestinal disorders
Abdominal Pain	0/140 (0%)		1/140 (0.7%)
Abdominal Pain Upper	0/140 (0%)		1/140 (0.7%)
Nausea	0/140 (0%)		1/140 (0.7%)
Upper Gastrointestinal Haemorrhage	0/140 (0%)		1/140 (0.7%)
Vomiting	0/140 (0%)		1/140 (0.7%)
General disorders
Chest Pain	1/140 (0.7%)		1/140 (0.7%)
Pyrexia	0/140 (0%)		1/140 (0.7%)
Hepatobiliary disorders
Cholecystitis	0/140 (0%)		1/140 (0.7%)
Infections and infestations
Gastroenteritis	0/140 (0%)		1/140 (0.7%)
Gastroenteritis Viral	1/140 (0.7%)		0/140 (0%)
Osteomyelitis	1/140 (0.7%)		0/140 (0%)
Pneumonia	0/140 (0%)		1/140 (0.7%)
Sepsis	1/140 (0.7%)		0/140 (0%)
Metabolism and nutrition disorders
Hyperkalaemia	0/140 (0%)		1/140 (0.7%)
Hypoglycaemia	1/140 (0.7%)		0/140 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	1/140 (0.7%)		0/140 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	1/140 (0.7%)		0/140 (0%)
Nervous system disorders
Thalamic infarction	1/140 (0.7%)		0/140 (0%)
Renal and urinary disorders
Haematuria	0/140 (0%)		1/140 (0.7%)
Urinary retention	0/140 (0%)		1/140 (0.7%)
Respiratory, thoracic and mediastinal disorders
Pleuritic pain	0/140 (0%)		1/140 (0.7%)
Other (Not Including Serious) Adverse Events
	ABT-335 Plus Rosuvastatin		Rosuvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/140 (38.6%)		60/140 (42.9%)
Gastrointestinal disorders
Constipation	4/140 (2.9%)		7/140 (5%)
Diarrhoea	3/140 (2.1%)		11/140 (7.9%)
Vomiting	1/140 (0.7%)		7/140 (5%)
General disorders
Fatigue	0/140 (0%)		10/140 (7.1%)
Oedema Peripheral	7/140 (5%)		11/140 (7.9%)
Infections and infestations
Upper Respiratory Tract Infection	5/140 (3.6%)		7/140 (5%)
Investigations
Blood Creatinine Increased	8/140 (5.7%)		2/140 (1.4%)
Glomerular Filtration Rate Decreased	12/140 (8.6%)		2/140 (1.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	6/140 (4.3%)		7/140 (5%)
Back Pain	4/140 (2.9%)		9/140 (6.4%)
Myalgia	3/140 (2.1%)		7/140 (5%)
Pain in Extremity	4/140 (2.9%)		8/140 (5.7%)
Nervous system disorders
Headache	5/140 (3.6%)		13/140 (9.3%)
Respiratory, thoracic and mediastinal disorders
Cough	6/140 (4.3%)		11/140 (7.9%)
Vascular disorders
Hypertension	8/140 (5.7%)		6/140 (4.3%)

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.