Trial Outcomes & Findings for A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF]) (NCT NCT05615363)

NCT ID: NCT05615363

Last Updated: 2025-10-17

Results Overview

Calculate the change in body weight from the baseline up to Day 8 (kg)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 157 participants
• Primary outcome timeframe: Baseline, Day 8
• Results posted on: 2025-10-17

Participant Flow

Participant milestones

Measure	Material A OPC 131461 10mg group	Material B OPC 131461 5mg group	Material C OPC 131461 2mg group	Material D OPC 131461 1mg group	Placebo Placebo
Overall Study STARTED	31	32	31	33	30
Overall Study COMPLETED	27	28	22	29	25
Overall Study NOT COMPLETED	4	4	9	4	5

Reasons for withdrawal

Measure	Material A OPC 131461 10mg group	Material B OPC 131461 5mg group	Material C OPC 131461 2mg group	Material D OPC 131461 1mg group	Placebo Placebo
Overall Study Adverse Event	0	4	4	3	1
Overall Study Physician Decision	2	0	4	1	3
Overall Study Protocol Violation	2	0	0	0	1
Overall Study Withdrawal by Subject	0	0	1	0	0

Baseline Characteristics

A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])

Baseline characteristics by cohort

Measure	Material A n=31 Participants OPC 131461 10mg group	Material B n=32 Participants OPC 131461 5mg group	Material C n=31 Participants OPC 131461 2mg group	Material D n=33 Participants OPC 131461 1mg group	Placebo n=30 Participants Placebo	Total n=157 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	22 Participants n=8 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	30 Participants n=4 Participants	25 Participants n=21 Participants	135 Participants n=8 Participants
Age, Continuous	73.5 Years STANDARD_DEVIATION 11.6 • n=5 Participants	75.2 Years STANDARD_DEVIATION 10.7 • n=7 Participants	75.3 Years STANDARD_DEVIATION 13.1 • n=5 Participants	76.7 Years STANDARD_DEVIATION 7.9 • n=4 Participants	76.4 Years STANDARD_DEVIATION 9.4 • n=21 Participants	75.4 Years STANDARD_DEVIATION 10.6 • n=8 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	19 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants	12 Participants n=21 Participants	58 Participants n=8 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants	22 Participants n=4 Participants	18 Participants n=21 Participants	99 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants	32 Participants n=7 Participants	31 Participants n=5 Participants	33 Participants n=4 Participants	30 Participants n=21 Participants	157 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Day 8

Population: The full analysis set includes all subjects who have been administered at least one treatment of the IMP, and for whom efficacy data after IMP administration are available.

Calculate the change in body weight from the baseline up to Day 8 (kg)

Outcome measures

Measure	Material A n=31 Participants OPC 131461 10mg group	Material B n=32 Participants OPC 131461 5mg group	Material C n=31 Participants OPC 131461 2mg group	Material D n=33 Participants OPC 131461 1mg group	Placebo n=30 Participants Placebo
Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8	-1.96 kg Interval -2.5 to -1.42	-1.74 kg Interval -2.28 to -1.2	-1.4 kg Interval -1.94 to -0.85	-1.84 kg Interval -2.36 to -1.31	-1.17 kg Interval -1.72 to -0.62

SECONDARY outcome

Timeframe: Baseline, Day15

Population: The full analysis set includes all subjects who have been administered at least one treatment of the IMP, and for whom efficacy data after IMP administration are available.

Calculate the percentage change in body weight from the baseline up to last assessment time point (the day after IMP administration) by Day 15 （％）

Outcome measures

Measure	Material A n=31 Participants OPC 131461 10mg group	Material B n=32 Participants OPC 131461 5mg group	Material C n=31 Participants OPC 131461 2mg group	Material D n=33 Participants OPC 131461 1mg group	Placebo n=30 Participants Placebo
Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 15	-2.12 kg Interval -2.8 to -1.44	-2.11 kg Interval -2.79 to -1.43	-1.72 kg Interval -2.41 to -1.03	-1.87 kg Interval -2.53 to -1.21	-1.38 kg Interval -2.07 to -0.69

SECONDARY outcome

Timeframe: Baseline, Day7

Population: The full analysis set includes all subjects who have been administered at least one treatment of the IMP, and for whom efficacy data after IMP administration are available.

The tibial margins or acrotarsia in a sitting position will be examined to assess the severity of edema according to the criteria in 0 : Absent, No pitting observed at all, 1:Mild,Slight pitting observed, 2:Moderate, Pitting observed, 3 : Severe,Apparent edema.

Improvement rates (percentages of subjects who have symptoms at baseline and show markedly improved or improved after IMP administration) and resolution rates (percentages of subjects who have symptoms at baseline and no symptoms after IMP administration) at the last assessment time point (the day of IMP administration) by Day 7.

Outcome measures

Measure	Material A n=22 Participants OPC 131461 10mg group	Material B n=23 Participants OPC 131461 5mg group	Material C n=24 Participants OPC 131461 2mg group	Material D n=24 Participants OPC 131461 1mg group	Placebo n=24 Participants Placebo
Improvement of or Change in Congestive Findings ( Lower Limb Edema ) From Baseline to Last Assessment Time Point (the Day of IMP Administration) by Day 7	16 Participants	18 Participants	9 Participants	19 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline, Day7

Population: The full analysis set includes all subjects who have been administered at least one treatment of the IMP, and for whom efficacy data after IMP administration are available.

The severity of pulmonary congestion will be determined according to the criteria in 0 : Absent, No congestion, 1:Mild,Pulmonary venous congestion, 2:Moderate, Interstitial pulmonary edema, 3 : Severe, Alveolar pulmonary edema.

Improvement rates (percentages of subjects who have symptoms at baseline and show markedly improved or improved after IMP administration) and resolution rates (percentages of subjects who have symptoms at baseline and no symptoms after IMP administration) at the last assessment time point (the day of IMP administration) by Day 7.

Outcome measures

Measure	Material A n=23 Participants OPC 131461 10mg group	Material B n=26 Participants OPC 131461 5mg group	Material C n=20 Participants OPC 131461 2mg group	Material D n=26 Participants OPC 131461 1mg group	Placebo n=24 Participants Placebo
Improvement of or Change in Congestive Findings ( Pulmonary Congestion ) From Baseline to Last Assessment Time Point (the Day of IMP Administration) by Day 7	21 Participants	19 Participants	10 Participants	22 Participants	18 Participants

Adverse Events

Material A

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Material B

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Material C

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Material D

Serious events: 1 serious events

Other events: 14 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	Material A n=31 participants at risk OPC 131461 10mg group	Material B n=32 participants at risk OPC 131461 5mg group	Material C n=31 participants at risk OPC 131461 2mg group	Material D n=33 participants at risk OPC 131461 1mg group	Placebo n=30 participants at risk Placebo
Cardiac disorders Angina pectoris	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.1% 1/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Cardiac disorders Arrhythmia	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.0% 1/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Cardiac disorders Cardiac failure	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.3% 1/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.3% 1/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.1% 1/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Nervous system disorders Cerebral infarction	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.3% 1/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.

Other adverse events

Measure	Material A n=31 participants at risk OPC 131461 10mg group	Material B n=32 participants at risk OPC 131461 5mg group	Material C n=31 participants at risk OPC 131461 2mg group	Material D n=33 participants at risk OPC 131461 1mg group	Placebo n=30 participants at risk Placebo
Gastrointestinal disorders Constipation	6.5% 2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.2% 2/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	12.9% 4/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	9.1% 3/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.7% 2/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Gastrointestinal disorders Diarrhoea	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.1% 1/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.2% 1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.1% 2/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.3% 1/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Gastrointestinal disorders Dry mouth	6.5% 2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.2% 1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.0% 1/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
General disorders Thirst	12.9% 4/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	12.5% 4/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	12.1% 4/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Infections and infestations Nasopharyngitis	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.0% 1/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.7% 2/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Infections and infestations COVID-19	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	10.0% 3/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Investigations Blood pressure decreased	6.5% 2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Metabolism and nutrition disorders Dehydration	9.7% 3/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.1% 1/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.2% 1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.1% 2/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.2% 2/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	16.1% 5/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.0% 1/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Renal and urinary disorders Acute kidney injury	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.1% 1/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.1% 2/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	0.00% 0/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
Vascular disorders Hypotension	3.2% 1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.1% 1/32 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.5% 2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	3.0% 1/33 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.	6.7% 2/30 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication. All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., Ltd.

Phone: +81-3-6361-7366

Email: CL_OPCJ_RDA_Team@otsuka.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place