Trial Outcomes & Findings for Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT) (NCT NCT01219855)
NCT ID: NCT01219855
Last Updated: 2016-08-25
Results Overview
The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
78 participants
Primary outcome timeframe
6 weeks
Results posted on
2016-08-25
Participant Flow
Subjects with Stage 3 chronic kidney disease, vitamin D insufficiency and secondary parahyperthyroidism were recruited from 16 sites within the US.
This trial randomized 78 subjects. One subject in the 90 µg treatment arm was lost to follow-up after randomization but before receiving study drug. This subject was excluded from the Intent to Treat population (ITT).
Participant milestones
| Measure |
Cohort 1: CTAP101 Capsules 60µg
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: Sugar Capsule
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 2: Sugar Capsule
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
17
|
13
|
14
|
|
Overall Study
COMPLETED
|
16
|
12
|
16
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
Baseline characteristics by cohort
| Measure |
Cohort 1: CTAP101 Capsules 60µg
n=17 Participants
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=16 Participants
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: Sugar Capsule
n=17 Participants
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=13 Participants
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 2: Sugar Capsule
n=14 Participants
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 17.79 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 16.14 • n=4 Participants
|
63.9 years
STANDARD_DEVIATION 11.47 • n=21 Participants
|
63.0 years
STANDARD_DEVIATION 13.39 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Per protocol
The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.
Outcome measures
| Measure |
Cohort 1: CTAP101 Capsules 60µg
n=16 Participants
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=14 Participants
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: Sugar Capsule
n=17 Participants
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=12 Participants
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 2: Sugar Capsule
n=14 Participants
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
|---|---|---|---|---|---|
|
Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).
|
100 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
91.7 percentage of participants
|
7.1 percentage of participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Per protocol
Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.
Outcome measures
| Measure |
Cohort 1: CTAP101 Capsules 60µg
n=16 Participants
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=14 Participants
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: Sugar Capsule
n=17 Participants
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=12 Participants
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 2: Sugar Capsule
n=14 Participants
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)
|
-32.77 percentage of change from baseline
Standard Deviation 22.778
|
-39.32 percentage of change from baseline
Standard Deviation 16.243
|
20.49 percentage of change from baseline
Standard Deviation 52.871
|
-20.86 percentage of change from baseline
Standard Deviation 21.549
|
13.18 percentage of change from baseline
Standard Deviation 30.185
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (6 weeks)Population: Per protocol population
Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)
Outcome measures
| Measure |
Cohort 1: CTAP101 Capsules 60µg
n=16 Participants
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=14 Participants
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: Sugar Capsule
n=17 Participants
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=12 Participants
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 2: Sugar Capsule
n=14 Participants
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum 25-hydroxyvitamin D at Week 6
|
43.25 ng/mL
Standard Deviation 16.519
|
63.69 ng/mL
Standard Deviation 17.826
|
-0.65 ng/mL
Standard Deviation 2.502
|
16.22 ng/mL
Standard Deviation 6.005
|
-1.89 ng/mL
Standard Deviation 4.913
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (6 weeks)Population: Per protocol population
Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups.
Outcome measures
| Measure |
Cohort 1: CTAP101 Capsules 60µg
n=16 Participants
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=14 Participants
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: Sugar Capsule
n=17 Participants
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=12 Participants
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 2: Sugar Capsule
n=14 Participants
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population
|
187.64 percentage of change from baseline
Standard Deviation 74.251
|
313.12 percentage of change from baseline
Standard Deviation 101.592
|
-2.67 percentage of change from baseline
Standard Deviation 13.069
|
90.90 percentage of change from baseline
Standard Deviation 62.189
|
-7.22 percentage of change from baseline
Standard Deviation 20.599
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (6 weeks)Population: Per protocol
Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)
Outcome measures
| Measure |
Cohort 1: CTAP101 Capsules 60µg
n=16 Participants
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=14 Participants
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: Sugar Capsule
n=17 Participants
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=12 Participants
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 2: Sugar Capsule
n=14 Participants
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
|---|---|---|---|---|---|
|
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6
|
11 participants
|
9 participants
|
2 participants
|
5 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (6 weeks)Population: Per protocol population
Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)
Outcome measures
| Measure |
Cohort 1: CTAP101 Capsules 60µg
n=16 Participants
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=14 Participants
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: Sugar Capsule
n=17 Participants
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=12 Participants
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 2: Sugar Capsule
n=14 Participants
Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
|---|---|---|---|---|---|
|
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6
|
12 participants
|
13 participants
|
2 participants
|
5 participants
|
1 participants
|
Adverse Events
Cohorts 1,2: Sugar Capsule
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 2: CTAP101 Capsules 30µg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 1: CTAP101 Capsules 60µg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 1: CTAP101 Capsules 90µg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohorts 1,2: Sugar Capsule
n=31 participants at risk
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=13 participants at risk
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 60µg
n=17 participants at risk
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=16 participants at risk
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Endocrine disorders
Hypoglycaemia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
Other adverse events
| Measure |
Cohorts 1,2: Sugar Capsule
n=31 participants at risk
Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
|
Cohort 2: CTAP101 Capsules 30µg
n=13 participants at risk
Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 60µg
n=17 participants at risk
Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
|
Cohort 1: CTAP101 Capsules 90µg
n=16 participants at risk
Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Contusion
|
9.7%
3/31 • Number of events 3 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
12.5%
2/16 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Investigations
Blood 25-hydroxycholecalciferol increased
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Investigations
Blood glucose increased
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Investigations
Body temperature increased
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Investigations
Vitamin D increased
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
15.4%
2/13 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
12.5%
2/16 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
12.5%
2/16 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Tremor
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Psychiatric disorders
Tearfulness
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Renal and urinary disorders
Pollakiuria
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Surgical and medical procedures
Asthma prophylaxis
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Vascular disorders
Hot flush
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Infections and infestations
Cystitis
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Gout
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
12.5%
2/16 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
General disorders
Vessel puncture site haematoma
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
General disorders
Flank pain
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Eschar
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Sunburn
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Investigations
Blood uric acid increased
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Hypogeusia
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Neuropathy peripheral
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Nervous system disorders
Sensory loss
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Psychiatric disorders
Depressed mood
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Psychiatric disorders
Restlessness
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Endocrine disorders
Hypoglycaemia
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Eye disorders
Vision blurred
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
15.4%
2/13 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
11.8%
2/17 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
5.9%
1/17 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
General disorders
Fatigue
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
6.2%
1/16 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
General disorders
Impaired healing
|
0.00%
0/31 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
7.7%
1/13 • Number of events 1 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
General disorders
Oedema peripheral
|
9.7%
3/31 • Number of events 3 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
12.5%
2/16 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
|
General disorders
Pyrexia
|
6.5%
2/31 • Number of events 2 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/13 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/17 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
0.00%
0/16 • 12 weeks (6 week treatment period, followed by 6 week follow-up period)
|
Additional Information
Douglass Laidlaw, PhD, Vice President, Medical Affairs
OPKO Health, Inc.
Phone: 305-575-4172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60