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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

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ClinicalTrials.gov Identifier: NCT00680017
Recruitment Status : Completed
First Posted : May 19, 2008
Results First Posted : July 16, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dyslipidemia
Kidney Disease
Interventions Drug: ABT-335 plus rosuvastatin
Drug: Rosuvastatin
Enrollment 280
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.
Pre-assignment Details  
Arm/Group Title ABT-335 Plus Rosuvastatin Rosuvastatin
Hide 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
Reason Not Completed
Adverse Event             13             7
Withdrawal by Subject             2             5
Lost to Follow-up             2             0
Arm/Group Title ABT-335 Plus Rosuvastatin Rosuvastatin Total
Hide 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 Number of Baseline Participants 140 140 280
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 280 participants
<=18 years
0
   0.0%
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 Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 140 participants 280 participants
65.1  (10.35) 67.4  (11.15) 66.2  (10.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 280 participants
Female
78
  55.7%
71
  50.7%
149
  53.2%
Male
62
  44.3%
69
  49.3%
131
  46.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 280 participants
United States 129 132 261
Puerto Rico 11 8 19
1.Primary Outcome
Title Median Percent Change in Triglycerides From Baseline to Week 8.
Hide Description Triglycerides were measured in milligrams/deciliter.
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 137 138
Median (Inter-Quartile Range)
Unit of Measure: percent change
-38.0
(-53.1 to -23.8)
-22.4
(-38.2 to -4.5)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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 [Not Specified]
2.Secondary Outcome
Title Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.
Hide Description High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 137 138
Least Squares Mean (Standard Error)
Unit of Measure: percent change
16.9  (1.44) 7.8  (1.43)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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.
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ABT-335 Plus Rosuvastatin Rosuvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   9/140 (6.43%)   11/140 (7.86%) 
Cardiac disorders     
Acute Coronary Syndrome  1/140 (0.71%)  0/140 (0.00%) 
Acute Myocardial Infarction  1/140 (0.71%)  0/140 (0.00%) 
Angina Unstable  0/140 (0.00%)  1/140 (0.71%) 
Coronary Artery Disease  0/140 (0.00%)  3/140 (2.14%) 
Myocardial Infarction  0/140 (0.00%)  2/140 (1.43%) 
Gastrointestinal disorders     
Abdominal Pain  0/140 (0.00%)  1/140 (0.71%) 
Abdominal Pain Upper  0/140 (0.00%)  1/140 (0.71%) 
Nausea  0/140 (0.00%)  1/140 (0.71%) 
Upper Gastrointestinal Haemorrhage  0/140 (0.00%)  1/140 (0.71%) 
Vomiting  0/140 (0.00%)  1/140 (0.71%) 
General disorders     
Chest Pain  1/140 (0.71%)  1/140 (0.71%) 
Pyrexia  0/140 (0.00%)  1/140 (0.71%) 
Hepatobiliary disorders     
Cholecystitis  0/140 (0.00%)  1/140 (0.71%) 
Infections and infestations     
Gastroenteritis  0/140 (0.00%)  1/140 (0.71%) 
Gastroenteritis Viral  1/140 (0.71%)  0/140 (0.00%) 
Osteomyelitis  1/140 (0.71%)  0/140 (0.00%) 
Pneumonia  0/140 (0.00%)  1/140 (0.71%) 
Sepsis  1/140 (0.71%)  0/140 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  0/140 (0.00%)  1/140 (0.71%) 
Hypoglycaemia  1/140 (0.71%)  0/140 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1/140 (0.71%)  0/140 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant  1/140 (0.71%)  0/140 (0.00%) 
Nervous system disorders     
Thalamic infarction  1/140 (0.71%)  0/140 (0.00%) 
Renal and urinary disorders     
Haematuria  0/140 (0.00%)  1/140 (0.71%) 
Urinary retention  0/140 (0.00%)  1/140 (0.71%) 
Respiratory, thoracic and mediastinal disorders     
Pleuritic pain  0/140 (0.00%)  1/140 (0.71%) 
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABT-335 Plus Rosuvastatin Rosuvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   54/140 (38.57%)   60/140 (42.86%) 
Gastrointestinal disorders     
Constipation  4/140 (2.86%)  7/140 (5.00%) 
Diarrhoea  3/140 (2.14%)  11/140 (7.86%) 
Vomiting  1/140 (0.71%)  7/140 (5.00%) 
General disorders     
Fatigue  0/140 (0.00%)  10/140 (7.14%) 
Oedema Peripheral  7/140 (5.00%)  11/140 (7.86%) 
Infections and infestations     
Upper Respiratory Tract Infection  5/140 (3.57%)  7/140 (5.00%) 
Investigations     
Blood Creatinine Increased  8/140 (5.71%)  2/140 (1.43%) 
Glomerular Filtration Rate Decreased  12/140 (8.57%)  2/140 (1.43%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  6/140 (4.29%)  7/140 (5.00%) 
Back Pain  4/140 (2.86%)  9/140 (6.43%) 
Myalgia  3/140 (2.14%)  7/140 (5.00%) 
Pain in Extremity  4/140 (2.86%)  8/140 (5.71%) 
Nervous system disorders     
Headache  5/140 (3.57%)  13/140 (9.29%) 
Respiratory, thoracic and mediastinal disorders     
Cough  6/140 (4.29%)  11/140 (7.86%) 
Vascular disorders     
Hypertension  8/140 (5.71%)  6/140 (4.29%) 
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Phone: +44 1509 645 895
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00680017     History of Changes
Other Study ID Numbers: M10-313
First Submitted: May 15, 2008
First Posted: May 19, 2008
Results First Submitted: April 25, 2012
Results First Posted: July 16, 2012
Last Update Posted: October 3, 2012