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A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525265
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cardiac Edema
Interventions Drug: OPC-41061(Tolvaptan)
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OPC-41061 7.5 mg OPC-41061 15 mg
Hide Arm/Group Description OPC-41061 7.5 mg/day OPC-41061 1.5 mg/day
Period Title: Overall Study
Started 10 10
Completed 9 10
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title OPC-41061 7.5 mg OPC-41061 15 mg Total
Hide Arm/Group Description OPC-41061 7.5 mg/day OPC-41061 15 mg/day Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  40.0%
4
  40.0%
8
  40.0%
>=65 years
6
  60.0%
6
  60.0%
12
  60.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
69.1  (13.6) 66.8  (10.2) 68.0  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
2
  20.0%
8
  40.0%
Male
4
  40.0%
8
  80.0%
12
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Body Weight
Hide Description The body weight change from baseline at the time of final trial drug administration
Time Frame Baseline, at the time of final trial drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPC-41061 7.5 mg OPC-41061 15 mg
Hide Arm/Group Description:
OPC-41061 7.5 mg/day
OPC-41061 15 mg/day
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Kg
-1.68  (1.83) -2.14  (1.45)
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OPC-41061 7.5 mg OPC-41061 15 mg
Hide Arm/Group Description OPC-41061 7.5 mg/day OPC-41061 15 mg/day
All-Cause Mortality
OPC-41061 7.5 mg OPC-41061 15 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
OPC-41061 7.5 mg OPC-41061 15 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/10 (10.00%)    
Cardiac disorders     
Ventricular Tachycardia * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)J
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OPC-41061 7.5 mg OPC-41061 15 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      9/10 (90.00%)    
Gastrointestinal disorders     
Constipation * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
Epigastric Discomfort * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
Vomiting * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
General disorders     
Feeling Hot * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Malaise * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Pyrexia * 1  2/10 (20.00%)  4 1/10 (10.00%)  1
Thirst * 1  4/10 (40.00%)  4 4/10 (40.00%)  4
Infections and infestations     
Nasopharyngitis * 1  2/10 (20.00%)  2 0/10 (0.00%)  0
Pharyngitis * 1  2/10 (20.00%)  2 0/10 (0.00%)  0
Urinary Tract Infection * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications     
Procedural Pain * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Investigations     
Blood Creatinine Increased * 1  2/10 (20.00%)  2 4/10 (40.00%)  5
Blood Potassium Increased * 1  1/10 (10.00%)  1 1/10 (10.00%)  1
Blood Pressure Decreased * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Blood Urea Increased * 1  2/10 (20.00%)  2 5/10 (50.00%)  5
Blood Uric Acid Increased * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
Blood Urine Present * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Faecal Occult Blood * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
Metabolism and nutrition disorders     
Decreased Appetite * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain * 1  2/10 (20.00%)  2 0/10 (0.00%)  0
Musculoskeletal Stiffness * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Nervous system disorders     
Altered State of Consciousness * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Dizziness * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
Psychiatric disorders     
Delirium * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Renal and urinary disorders     
Pollakiuria * 1  1/10 (10.00%)  1 2/10 (20.00%)  2
Reproductive system and breast disorders     
Oedema Genital * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Genital Haemorrhage * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Pharyngolaryngeal Pain * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Upper Respiratory Tract Inflammation * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
Dematitis Contact * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders     
Haematoma * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
Orthostatic Hypotension * 1  0/10 (0.00%)  0 1/10 (10.00%)  1
Wound Haemorrhage * 1  1/10 (10.00%)  1 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)J
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7314
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00525265    
Other Study ID Numbers: 156-06-004
First Submitted: September 3, 2007
First Posted: September 5, 2007
Results First Submitted: November 1, 2013
Results First Posted: December 25, 2013
Last Update Posted: December 25, 2013