Trial Outcomes & Findings for A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure) (NCT NCT00525265)
NCT ID: NCT00525265
Last Updated: 2013-12-25
Results Overview
The body weight change from baseline at the time of final trial drug administration
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
Baseline, at the time of final trial drug administration
Results posted on
2013-12-25
Participant Flow
Participant milestones
| Measure |
OPC-41061 7.5 mg
OPC-41061 7.5 mg/day
|
OPC-41061 15 mg
OPC-41061 1.5 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
OPC-41061 7.5 mg
OPC-41061 7.5 mg/day
|
OPC-41061 15 mg
OPC-41061 1.5 mg/day
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
Baseline characteristics by cohort
| Measure |
OPC-41061 7.5 mg
n=10 Participants
OPC-41061 7.5 mg/day
|
OPC-41061 15 mg
n=10 Participants
OPC-41061 15 mg/day
|
Total
n=20 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
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age Continuous
|
69.1 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
68.0 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, at the time of final trial drug administrationThe body weight change from baseline at the time of final trial drug administration
Outcome measures
| Measure |
OPC-41061 7.5 mg
n=10 Participants
OPC-41061 7.5 mg/day
|
OPC-41061 15 mg
n=10 Participants
OPC-41061 15 mg/day
|
|---|---|---|
|
Body Weight
|
-1.68 Kg
Standard Deviation 1.83
|
-2.14 Kg
Standard Deviation 1.45
|
Adverse Events
OPC-41061 7.5 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
OPC-41061 15 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-41061 7.5 mg
n=10 participants at risk
OPC-41061 7.5 mg/day
|
OPC-41061 15 mg
n=10 participants at risk
OPC-41061 15 mg/day
|
|---|---|---|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
Other adverse events
| Measure |
OPC-41061 7.5 mg
n=10 participants at risk
OPC-41061 7.5 mg/day
|
OPC-41061 15 mg
n=10 participants at risk
OPC-41061 15 mg/day
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
General disorders
Feeling Hot
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
General disorders
Malaise
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Number of events 4 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
General disorders
Thirst
|
40.0%
4/10 • Number of events 4 • 7 days
|
40.0%
4/10 • Number of events 4 • 7 days
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
2/10 • Number of events 2 • 7 days
|
0.00%
0/10 • 7 days
|
|
Infections and infestations
Pharyngitis
|
20.0%
2/10 • Number of events 2 • 7 days
|
0.00%
0/10 • 7 days
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Investigations
Blood Creatinine Increased
|
20.0%
2/10 • Number of events 2 • 7 days
|
40.0%
4/10 • Number of events 5 • 7 days
|
|
Investigations
Blood Potassium Increased
|
10.0%
1/10 • Number of events 1 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Investigations
Blood Pressure Decreased
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Investigations
Blood Urea Increased
|
20.0%
2/10 • Number of events 2 • 7 days
|
50.0%
5/10 • Number of events 5 • 7 days
|
|
Investigations
Blood Uric Acid Increased
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Investigations
Blood Urine Present
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Investigations
Faecal Occult Blood
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
2/10 • Number of events 2 • 7 days
|
0.00%
0/10 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Nervous system disorders
Altered State of Consciousness
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Psychiatric disorders
Delirium
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • Number of events 1 • 7 days
|
20.0%
2/10 • Number of events 2 • 7 days
|
|
Reproductive system and breast disorders
Oedema Genital
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Reproductive system and breast disorders
Genital Haemorrhage
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Skin and subcutaneous tissue disorders
Dematitis Contact
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Vascular disorders
Haematoma
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Vascular disorders
Wound Haemorrhage
|
10.0%
1/10 • Number of events 1 • 7 days
|
0.00%
0/10 • 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