Trial Outcomes & Findings for 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 (NCT NCT00680017)
NCT ID: NCT00680017
Last Updated: 2012-10-03
Results Overview
Triglycerides were measured in milligrams/deciliter.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
280 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2012-10-03
Participant Flow
280 participants were randomized and treated at 84 sites in the United States and Puerto Rico between 23 July 2008 and 02 March 2011.
Participant milestones
| Measure |
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
|
Rosuvastatin
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
140
|
|
Overall Study
COMPLETED
|
123
|
128
|
|
Overall Study
NOT COMPLETED
|
17
|
12
|
Reasons for withdrawal
| Measure |
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
|
Rosuvastatin
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
ABT-335 Plus Rosuvastatin
n=140 Participants
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
|
Rosuvastatin
n=140 Participants
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Age Continuous
|
65.1 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 11.15 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=5 Participants
|
132 participants
n=7 Participants
|
261 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: 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.
Triglycerides were measured in milligrams/deciliter.
Outcome measures
| Measure |
ABT-335 Plus Rosuvastatin
n=137 Participants
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
|
Rosuvastatin
n=138 Participants
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
|
|---|---|---|
|
Median Percent Change in Triglycerides From Baseline to Week 8.
|
-38.0 percent change
Interval -53.1 to -23.8
|
-22.4 percent change
Interval -38.2 to -4.5
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: 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.
High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).
Outcome measures
| Measure |
ABT-335 Plus Rosuvastatin
n=137 Participants
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
|
Rosuvastatin
n=138 Participants
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
|
|---|---|---|
|
Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.
|
16.9 percent change
Standard Error 1.44
|
7.8 percent change
Standard Error 1.43
|
Adverse Events
ABT-335 Plus Rosuvastatin
Serious events: 9 serious events
Other events: 54 other events
Deaths: 0 deaths
Rosuvastatin
Serious events: 11 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-335 Plus Rosuvastatin
n=140 participants at risk
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
|
Rosuvastatin
n=140 participants at risk
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
|
|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/140 • 24 weeks
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.
|
2.1%
3/140 • 24 weeks
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.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/140 • 24 weeks
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.
|
1.4%
2/140 • 24 weeks
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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
General disorders
Chest Pain
|
0.71%
1/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
General disorders
Pyrexia
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Infections and infestations
Osteomyelitis
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Infections and infestations
Sepsis
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Nervous system disorders
Thalamic infarction
|
0.71%
1/140 • 24 weeks
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.
|
0.00%
0/140 • 24 weeks
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.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/140 • 24 weeks
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.
|
0.71%
1/140 • 24 weeks
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.
|
Other adverse events
| Measure |
ABT-335 Plus Rosuvastatin
n=140 participants at risk
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
|
Rosuvastatin
n=140 participants at risk
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.9%
4/140 • 24 weeks
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.
|
5.0%
7/140 • 24 weeks
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
3/140 • 24 weeks
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.
|
7.9%
11/140 • 24 weeks
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.71%
1/140 • 24 weeks
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.
|
5.0%
7/140 • 24 weeks
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.
|
|
General disorders
Fatigue
|
0.00%
0/140 • 24 weeks
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.
|
7.1%
10/140 • 24 weeks
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.
|
|
General disorders
Oedema Peripheral
|
5.0%
7/140 • 24 weeks
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.
|
7.9%
11/140 • 24 weeks
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.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
5/140 • 24 weeks
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.
|
5.0%
7/140 • 24 weeks
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.
|
|
Investigations
Blood Creatinine Increased
|
5.7%
8/140 • 24 weeks
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.
|
1.4%
2/140 • 24 weeks
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.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
8.6%
12/140 • 24 weeks
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.
|
1.4%
2/140 • 24 weeks
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
6/140 • 24 weeks
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.
|
5.0%
7/140 • 24 weeks
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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.9%
4/140 • 24 weeks
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.
|
6.4%
9/140 • 24 weeks
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
3/140 • 24 weeks
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.
|
5.0%
7/140 • 24 weeks
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.9%
4/140 • 24 weeks
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.
|
5.7%
8/140 • 24 weeks
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.
|
|
Nervous system disorders
Headache
|
3.6%
5/140 • 24 weeks
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.
|
9.3%
13/140 • 24 weeks
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
6/140 • 24 weeks
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.
|
7.9%
11/140 • 24 weeks
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.
|
|
Vascular disorders
Hypertension
|
5.7%
8/140 • 24 weeks
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.
|
4.3%
6/140 • 24 weeks
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER