Trial Outcomes & Findings for A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure) (NCT NCT00234104)
NCT ID: NCT00234104
Last Updated: 2013-12-25
Results Overview
The body weight change from baseline following final trial drug administration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Baseline, at the time of final trial drug administration
Results posted on
2013-12-25
Participant Flow
Participant milestones
| Measure |
Placebo
OPC-41061 0 mg/day
|
15 mg of OPC-41061
OPC-41061 15 mg/day
|
30 mg of OPC-41061
OPC-41061 30 mg/day
|
45 mg of OPC-41061
OPC-41061 45 mg/day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
34
|
29
|
|
Overall Study
COMPLETED
|
26
|
28
|
29
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
5
|
8
|
Reasons for withdrawal
| Measure |
Placebo
OPC-41061 0 mg/day
|
15 mg of OPC-41061
OPC-41061 15 mg/day
|
30 mg of OPC-41061
OPC-41061 30 mg/day
|
45 mg of OPC-41061
OPC-41061 45 mg/day
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
3
|
5
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
2
|
Baseline Characteristics
A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
OPC-41061 0 mg/day
|
15 mg of OPC-41061
n=28 Participants
OPC-41061 15 mg/day
|
30 mg of OPC-41061
n=33 Participants
OPC-41061 30 mg/day
|
45 mg of OPC-41061
n=28 Participants
OPC-41061 45 mg/day
|
Total
n=118 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
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
46 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
72 Participants
n=36 Participants
|
|
Age Continuous
|
67.9 years
STANDARD_DEVIATION 9.4 • n=93 Participants
|
66.9 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
66.4 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
62.6 years
STANDARD_DEVIATION 12.5 • n=483 Participants
|
66.0 years
STANDARD_DEVIATION 11.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
82 Participants
n=36 Participants
|
|
Region of Enrollment
Japan
|
29 participants
n=93 Participants
|
28 participants
n=4 Participants
|
33 participants
n=27 Participants
|
28 participants
n=483 Participants
|
118 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, at the time of final trial drug administrationPopulation: 1 Subject of Placebo arm who experienced a serious adverse event was excluded from efficacy analysis set because the emergency code was broken.
The body weight change from baseline following final trial drug administration
Outcome measures
| Measure |
Placebo
n=28 Participants
OPC-41061 0 mg/day
|
15 mg of OPC-41061
n=28 Participants
OPC-41061 15 mg/day
|
30 mg of OPC-41061
n=33 Participants
OPC-41061 30 mg/day
|
45 mg of OPC-41061
n=28 Participants
OPC-41061 45 mg/day
|
|---|---|---|---|---|
|
Body Weight
|
-0.53 Kg
Standard Deviation 0.96
|
-1.62 Kg
Standard Deviation 1.55
|
-1.35 Kg
Standard Deviation 1.54
|
-1.85 Kg
Standard Deviation 1.10
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
15 mg of OPC-41061
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
30 mg of OPC-41061
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
45 mg of OPC-41061
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=29 participants at risk
OPC-41061 0 mg/day
|
15 mg of OPC-41061
n=28 participants at risk
OPC-41061 15 mg/day
|
30 mg of OPC-41061
n=33 participants at risk
OPC-41061 30 mg/day
|
45 mg of OPC-41061
n=28 participants at risk
OPC-41061 45 mg/day
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.4%
1/29 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
3.4%
1/29 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
|
Gastrointestinal disorders
Umbilical Hernia
|
3.4%
1/29 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
|
General disorders
Sudden Death
|
3.4%
1/29 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
0.00%
0/33 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
0.00%
0/33 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
Other adverse events
| Measure |
Placebo
n=29 participants at risk
OPC-41061 0 mg/day
|
15 mg of OPC-41061
n=28 participants at risk
OPC-41061 15 mg/day
|
30 mg of OPC-41061
n=33 participants at risk
OPC-41061 30 mg/day
|
45 mg of OPC-41061
n=28 participants at risk
OPC-41061 45 mg/day
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
|
Gastrointestinal disorders
Constipation
|
10.3%
3/29 • Number of events 3 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
18.2%
6/33 • Number of events 6 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
9.1%
3/33 • Number of events 3 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 2 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
|
General disorders
Malaise
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
0.00%
0/28 • 7 days
|
|
General disorders
Oedema Peripheral
|
6.9%
2/29 • Number of events 2 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
|
General disorders
Thirst
|
10.3%
3/29 • Number of events 3 • 7 days
|
21.4%
6/28 • Number of events 6 • 7 days
|
27.3%
9/33 • Number of events 9 • 7 days
|
53.6%
15/28 • Number of events 15 • 7 days
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
0.00%
0/28 • 7 days
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/29 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/29 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
0.00%
0/28 • 7 days
|
|
Investigations
Blood Osmolarity Increased
|
0.00%
0/29 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
|
Investigations
Blood Potassium Increased
|
3.4%
1/29 • Number of events 1 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
0.00%
0/33 • 7 days
|
7.1%
2/28 • Number of events 3 • 7 days
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/29 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
|
Investigations
Blood Urea Increased
|
3.4%
1/29 • Number of events 1 • 7 days
|
10.7%
3/28 • Number of events 3 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
|
Investigations
Blood Uric Acid Increased
|
0.00%
0/29 • 7 days
|
21.4%
6/28 • Number of events 7 • 7 days
|
12.1%
4/33 • Number of events 4 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
3.4%
1/29 • Number of events 1 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/29 • 7 days
|
0.00%
0/28 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
0.00%
0/28 • 7 days
|
|
Investigations
Platelet Count Decreased
|
3.4%
1/29 • Number of events 1 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
6.1%
2/33 • Number of events 2 • 7 days
|
0.00%
0/28 • 7 days
|
|
Investigations
Protein Urine Present
|
10.3%
3/29 • Number of events 3 • 7 days
|
0.00%
0/28 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • Number of events 2 • 7 days
|
0.00%
0/28 • 7 days
|
9.1%
3/33 • Number of events 3 • 7 days
|
21.4%
6/28 • Number of events 6 • 7 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • 7 days
|
10.7%
3/28 • Number of events 3 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • 7 days
|
10.7%
3/28 • Number of events 3 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
|
Psychiatric disorders
Insomnia
|
6.9%
2/29 • Number of events 2 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
0.00%
0/28 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
2/29 • Number of events 2 • 7 days
|
0.00%
0/28 • 7 days
|
3.0%
1/33 • Number of events 1 • 7 days
|
3.6%
1/28 • Number of events 1 • 7 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/29 • 7 days
|
7.1%
2/28 • Number of events 2 • 7 days
|
0.00%
0/33 • 7 days
|
0.00%
0/28 • 7 days
|
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