Trial Outcomes & Findings for A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) (NCT NCT00544869)
NCT ID: NCT00544869
Last Updated: 2014-01-30
Results Overview
The change of body weight from baseline at final observation
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
Baseline, Day 14 or at the time of final drug administration
Results posted on
2014-01-30
Participant Flow
Participant milestones
| Measure |
Stopped at End of Treatment Period 1
Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
|
Continued at 15 mg/Day
Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
|
Dose Escalated to 30 mg/Day
Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
14
|
2
|
|
Overall Study
COMPLETED
|
24
|
12
|
2
|
|
Overall Study
NOT COMPLETED
|
12
|
2
|
0
|
Reasons for withdrawal
| Measure |
Stopped at End of Treatment Period 1
Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
|
Continued at 15 mg/Day
Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
|
Dose Escalated to 30 mg/Day
Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
|
|---|---|---|---|
|
Overall Study
Rsolution of congenitive symptoms
|
3
|
0
|
0
|
|
Overall Study
Adverse Event
|
6
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
Baseline Characteristics
A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)
Baseline characteristics by cohort
| Measure |
Stopped at End of Treatment Period 1
n=36 Participants
Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
|
Continued at 15 mg/Day
n=13 Participants
Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
|
Dose Escalated to 30 mg/Day
n=2 Participants
Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 9.5 • n=93 Participants
|
67.2 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
78.5 years
STANDARD_DEVIATION 2.1 • n=27 Participants
|
70.5 years
STANDARD_DEVIATION 10.4 • n=483 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
Region of Enrollment
Japan
|
36 participants
n=93 Participants
|
13 participants
n=4 Participants
|
2 participants
n=27 Participants
|
51 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 14 or at the time of final drug administrationThe change of body weight from baseline at final observation
Outcome measures
| Measure |
Stopped at End of Treatment Period 1
n=36 Participants
|
Continued at 15 mg/Day
n=13 Participants
|
Dose Escalated to 30 mg/Day
n=2 Participants
|
|---|---|---|---|
|
Body Weight
|
-2.05 Kg
Standard Deviation 1.86
|
-1.31 Kg
Standard Deviation 2.95
|
-2.9 Kg
Standard Deviation 2.69
|
Adverse Events
Stopped at End of Treatment Period 1
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Continued at 15 mg/Day
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Dose Escalated to 30 mg/Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stopped at End of Treatment Period 1
n=36 participants at risk
Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
|
Continued at 15 mg/Day
n=13 participants at risk
Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
|
Dose Escalated to 30 mg/Day
n=2 participants at risk
Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Cardiac disorders
Intracardiac Thrombus
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Nervous system disorders
Cerebral Artery Embolism
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Renal and urinary disorders
Renal Failure Chronic
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
Other adverse events
| Measure |
Stopped at End of Treatment Period 1
n=36 participants at risk
Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
|
Continued at 15 mg/Day
n=13 participants at risk
Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
|
Dose Escalated to 30 mg/Day
n=2 participants at risk
Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
15.4%
2/13 • Number of events 2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Cardiac disorders
Ventricular Tachycardia
|
11.1%
4/36 • Number of events 4 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
50.0%
1/2 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Gastrointestinal disorders
Constipation
|
13.9%
5/36 • Number of events 5 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
15.4%
2/13 • Number of events 2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
General disorders
Chest Pain
|
5.6%
2/36 • Number of events 2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
General disorders
Pain
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
General disorders
Thirst
|
38.9%
14/36 • Number of events 14 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
46.2%
6/13 • Number of events 6 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Alanine Aminotransferase Increased
|
8.3%
3/36 • Number of events 3 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.3%
3/36 • Number of events 3 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
50.0%
1/2 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Blood Creatinine Increased
|
11.1%
4/36 • Number of events 4 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
30.8%
4/13 • Number of events 4 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
50.0%
1/2 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Blood Glucose Increased
|
11.1%
4/36 • Number of events 4 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
30.8%
4/13 • Number of events 4 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Blood Potassium Increased
|
8.3%
3/36 • Number of events 3 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
23.1%
3/13 • Number of events 3 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Blood Urea Increased
|
16.7%
6/36 • Number of events 6 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
30.8%
4/13 • Number of events 4 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
50.0%
1/2 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Blood Uric Acid Increased
|
16.7%
6/36 • Number of events 6 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
30.8%
4/13 • Number of events 5 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
50.0%
1/2 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Blood Urine Present
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
Glucose Urine Present
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/13 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
50.0%
1/2 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
15.4%
2/13 • Number of events 2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
15.4%
2/13 • Number of events 2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
2/36 • Number of events 2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Renal and urinary disorders
Renal Impairment
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
1/36 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
23.1%
3/13 • Number of events 3 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
2/36 • Number of events 2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/36 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
7.7%
1/13 • Number of events 1 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
0.00%
0/2 • 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7314
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place