Trial Outcomes & Findings for A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration (NCT NCT02331680)
NCT ID: NCT02331680
Last Updated: 2019-10-22
Results Overview
Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Baseline，End of the treatment
Results posted on
2019-10-22
Participant Flow
Participant milestones
| Measure |
OPC-41061 15mg/Day
OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
OPC-41061 30mg/Day
OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
Placebo
OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
44
|
|
Overall Study
COMPLETED
|
34
|
36
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
15
|
Reasons for withdrawal
| Measure |
OPC-41061 15mg/Day
OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
OPC-41061 30mg/Day
OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
Placebo
OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
|
Overall Study
Met withdrawal criteria
|
2
|
2
|
5
|
|
Overall Study
Non-compliance with study drug
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
Baseline Characteristics
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
Baseline characteristics by cohort
| Measure |
OPC-41061 15mg/Day
n=40 Participants
OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
OPC-41061 30mg/Day
n=40 Participants
OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
Placebo
n=44 Participants
OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
Total
n=124 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
44 participants
n=5 Participants
|
122 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline，End of the treatmentChange in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
Outcome measures
| Measure |
OPC-41061 15mg/Day
n=38 Participants
OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
OPC-41061 30mg/Day
n=38 Participants
OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
Placebo
n=42 Participants
OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Daily Urine Volume
|
169.2 mL
Standard Deviation 422.2
|
111.8 mL
Standard Deviation 557.7
|
-259.9 mL
Standard Deviation 463.8
|
SECONDARY outcome
Timeframe: Baseline，End of the treatmentChange in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics.
Outcome measures
| Measure |
OPC-41061 15mg/Day
n=39 Participants
OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
OPC-41061 30mg/Day
n=39 Participants
OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
Placebo
n=43 Participants
OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
|---|---|---|---|
|
Change in Total Volume of Fluid Removed by Dialysis Per Week
|
485.9 mL
Standard Deviation 1979.3
|
375.4 mL
Standard Deviation 1721.8
|
1099.5 mL
Standard Deviation 2160.5
|
Adverse Events
OPC-41061 15mg/Day
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
OPC-41061 30mg/Day
Serious events: 7 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-41061 15mg/Day
n=39 participants at risk
OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
OPC-41061 30mg/Day
n=39 participants at risk
OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
Placebo
n=44 participants at risk
OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Cardiac disorders
Angina pectoris
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Cardiac disorders
Cardiac failure
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
4.5%
2/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Eye disorders
Macular hole
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
General disorders
Decreased activity
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
General disorders
Malaise
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Investigations
Occult blood
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Infections and infestations
Pneumonia
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Infections and infestations
Pyelonephritis
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Infections and infestations
Renal cyst infection
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
Other adverse events
| Measure |
OPC-41061 15mg/Day
n=39 participants at risk
OPC-41061 (15 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
OPC-41061 30mg/Day
n=39 participants at risk
OPC-41061 (30 mg/day) was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
Placebo
n=44 participants at risk
OPC-41061 placebo was orally administered once daily after breakfast on off-dialysis days for 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
23.1%
9/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
35.9%
14/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
22.7%
10/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
17.9%
7/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
6.8%
3/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
9.1%
4/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Injury, poisoning and procedural complications
Wound
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
6.8%
3/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
12.8%
5/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
9.1%
4/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
10.3%
4/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Investigations
Blood potassium increased
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
9.1%
4/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Investigations
Blood pressure decreased
|
7.7%
3/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
4.5%
2/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
3/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
6.8%
3/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
General disorders
Thirst
|
10.3%
4/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
7.7%
3/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Cardiac disorders
Angina pectoris
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.6%
1/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
2.3%
1/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
|
Psychiatric disorders
Insomnia
|
5.1%
2/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/39 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
0.00%
0/44 • Treatment period
One subject in OPC-41061 15 mg group and one subject in OPC-41061 30 mg group were excluded from all datasets due to the loss of source documents at the site.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place