Trial Outcomes & Findings for A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure) (NCT NCT00462670)

NCT ID: NCT00462670

Last Updated: 2014-02-04

Results Overview

Change in body weight from baseline at the time of final trial drug administration

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 110 participants
• Primary outcome timeframe: baseline, Day 7 or at the time of final trial drug administration
• Results posted on: 2014-02-04

Participant Flow

Participant milestones

Measure	Placebo 0mg OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration	OPC-41061 15mg 15mg OPC-41061 OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration
Overall Study STARTED	57	53
Overall Study COMPLETED	52	46
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Placebo 0mg OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration	OPC-41061 15mg 15mg OPC-41061 OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration
Overall Study Adverse Event	3	5
Overall Study Lack of Efficacy	1	0
Overall Study Protocol Violation	1	0
Overall Study Resolution of signs and symptoms	0	2

Baseline Characteristics

A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

Baseline characteristics by cohort

Measure	Placebo n=57 Participants 0 mg of OPC-41061 per day for 7days p.o. administration	OPC-41061 n=53 Participants 15mg of OPC-41061 per day for 7days p.o. administration	Total n=110 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	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	41 Participants n=7 Participants	79 Participants n=5 Participants
Age, Continuous	71.0 years STANDARD_DEVIATION 10.9 • n=5 Participants	71.3 years STANDARD_DEVIATION 10.6 • n=7 Participants	71.2 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	35 Participants n=7 Participants	74 Participants n=5 Participants
Region of Enrollment Japan	57 participants n=5 Participants	53 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, Day 7 or at the time of final trial drug administration

Change in body weight from baseline at the time of final trial drug administration

Outcome measures

Measure	Placebo n=57 Participants 0mg OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration	OPC-41061 15mg n=53 Participants 15mg OPC-41061 OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration
Body Weight (Amount of Change)	-0.45 Kg Standard Deviation 0.93	-1.54 Kg Standard Deviation 1.61

SECONDARY outcome

Timeframe: baseline, Day 7 or at the time of final trial drug administration

Percent change in body weight from baseline at the time of final trial drug administration

Outcome measures

Measure	Placebo n=57 Participants 0mg OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration	OPC-41061 15mg n=53 Participants 15mg OPC-41061 OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration
Body Weight (Percent Change)	-0.77 percentage of body weight (Kg) Standard Deviation 1.65	-2.50 percentage of body weight (Kg) Standard Deviation 2.55

Adverse Events

Placebo

Serious events: 7 serious events

Other events: 31 other events

Deaths: 0 deaths

OPC-41061 15mg

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=57 participants at risk 0 mg of OPC-41061 per day for 7days p.o. administration	OPC-41061 15mg n=53 participants at risk 15 mg of OPC-41061 per day for 7days p.o. administration
Cardiac disorders Atrial Fibrillation	0.00% 0/57 • 7 days	1.9% 1/53 • Number of events 1 • 7 days
Cardiac disorders Cardiac Failure	3.5% 2/57 • Number of events 2 • 7 days	1.9% 1/53 • Number of events 1 • 7 days
Cardiac disorders Ventricular Tachycardia	1.8% 1/57 • Number of events 1 • 7 days	0.00% 0/53 • 7 days
General disorders Pyrexia	1.8% 1/57 • Number of events 1 • 7 days	0.00% 0/53 • 7 days
Injury, poisoning and procedural complications Femoral neck fracture	1.8% 1/57 • Number of events 1 • 7 days	0.00% 0/53 • 7 days
Metabolism and nutrition disorders Hyperkalaemia	1.8% 1/57 • Number of events 1 • 7 days	0.00% 0/53 • 7 days
Nervous system disorders Cerebral infarction	1.8% 1/57 • Number of events 1 • 7 days	0.00% 0/53 • 7 days
Renal and urinary disorders Renal failure chronic	0.00% 0/57 • 7 days	1.9% 1/53 • Number of events 1 • 7 days

Other adverse events

Measure	Placebo n=57 participants at risk 0 mg of OPC-41061 per day for 7days p.o. administration	OPC-41061 15mg n=53 participants at risk 15 mg of OPC-41061 per day for 7days p.o. administration
Cardiac disorders Ventricular Extrasystoles	3.5% 2/57 • Number of events 2 • 7 days	0.00% 0/53 • 7 days
Gastrointestinal disorders Constipation	5.3% 3/57 • Number of events 3 • 7 days	17.0% 9/53 • Number of events 10 • 7 days
Gastrointestinal disorders Diarrhoea	3.5% 2/57 • Number of events 2 • 7 days	3.8% 2/53 • Number of events 2 • 7 days
Gastrointestinal disorders Nausea	0.00% 0/57 • 7 days	5.7% 3/53 • Number of events 3 • 7 days
General disorders Face Oedema	3.5% 2/57 • Number of events 2 • 7 days	0.00% 0/53 • 7 days
General disorders Malaise	0.00% 0/57 • 7 days	5.7% 3/53 • Number of events 3 • 7 days
General disorders Pyrexia	3.5% 2/57 • Number of events 2 • 7 days	0.00% 0/53 • 7 days
General disorders Thirst	1.8% 1/57 • Number of events 1 • 7 days	17.0% 9/53 • Number of events 9 • 7 days
Infections and infestations Nasopharyngitis	5.3% 3/57 • Number of events 3 • 7 days	1.9% 1/53 • Number of events 1 • 7 days
Investigations Blood Creatinine Increased	12.3% 7/57 • Number of events 7 • 7 days	7.5% 4/53 • Number of events 4 • 7 days
Investigations Blood Potassium Increased	7.0% 4/57 • Number of events 4 • 7 days	5.7% 3/53 • Number of events 3 • 7 days
Investigations Blood Urea Increased	17.5% 10/57 • Number of events 10 • 7 days	9.4% 5/53 • Number of events 5 • 7 days
Investigations Blood Uric Acid Increased	5.3% 3/57 • Number of events 3 • 7 days	5.7% 3/53 • Number of events 3 • 7 days
Metabolism and nutrition disorders Hypoglycaemia	3.5% 2/57 • Number of events 4 • 7 days	0.00% 0/53 • 7 days
Nervous system disorders Dizziness	0.00% 0/57 • 7 days	3.8% 2/53 • Number of events 2 • 7 days
Nervous system disorders Headache	0.00% 0/57 • 7 days	3.8% 2/53 • Number of events 2 • 7 days
Renal and urinary disorders Pollakiuria	0.00% 0/57 • 7 days	9.4% 5/53 • Number of events 5 • 7 days
Respiratory, thoracic and mediastinal disorders Epistaxis	5.3% 3/57 • Number of events 3 • 7 days	3.8% 2/53 • Number of events 2 • 7 days
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.5% 2/57 • Number of events 2 • 7 days	0.00% 0/53 • 7 days
Skin and subcutaneous tissue disorders Haemorrhage Subcutaneous	3.5% 2/57 • Number of events 3 • 7 days	0.00% 0/53 • 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