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A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)

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ClinicalTrials.gov Identifier: NCT00544869
Recruitment Status : Completed
First Posted : October 16, 2007
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cardiac Edema
Intervention Drug: OPC-41061 (Tolvaptan)
Enrollment 52

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stopped at End of Treatment Period 1 Continued at 15 mg/Day Dose Escalated to 30 mg/Day
Hide Arm/Group Description Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2) Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
Period Title: Overall Study
Started 36 14 2
Completed 24 12 2
Not Completed 12 2 0
Reason Not Completed
Rsolution of congenitive symptoms             3             0             0
Adverse Event             6             1             0
Lack of Efficacy             1             1             0
Physician Decision             2             0             0
Arm/Group Title Stopped at End of Treatment Period 1 Continued at 15 mg/Day Dose Escalated to 30 mg/Day Total
Hide Arm/Group Description Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2) Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2) Total of all reporting groups
Overall Number of Baseline Participants 36 13 2 51
Hide Baseline Analysis Population Description
1 Subject of Arm "Continued at 15 mg/day" was excluded from analysis because of GCP incompliance
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 13 participants 2 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  19.4%
4
  30.8%
0
   0.0%
11
  21.6%
>=65 years
29
  80.6%
9
  69.2%
2
 100.0%
40
  78.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 13 participants 2 participants 51 participants
71.3  (9.5) 67.2  (12.7) 78.5  (2.1) 70.5  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 13 participants 2 participants 51 participants
Female
11
  30.6%
2
  15.4%
1
  50.0%
14
  27.5%
Male
25
  69.4%
11
  84.6%
1
  50.0%
37
  72.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 36 participants 13 participants 2 participants 51 participants
36 13 2 51
1.Primary Outcome
Title Body Weight
Hide Description The change of body weight from baseline at final observation
Time Frame Baseline, Day 14 or at the time of final drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stopped at End of Treatment Period 1 Continued at 15 mg/Day Dose Escalated to 30 mg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 36 13 2
Mean (Standard Deviation)
Unit of Measure: Kg
-2.05  (1.86) -1.31  (2.95) -2.9  (2.69)
Time Frame 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stopped at End of Treatment Period 1 Continued at 15 mg/Day Dose Escalated to 30 mg/Day
Hide Arm/Group Description Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2) Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
All-Cause Mortality
Stopped at End of Treatment Period 1 Continued at 15 mg/Day Dose Escalated to 30 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stopped at End of Treatment Period 1 Continued at 15 mg/Day Dose Escalated to 30 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/36 (8.33%)      1/13 (7.69%)      0/2 (0.00%)    
Cardiac disorders       
Cardiac Failure * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Intracardiac Thrombus * 1  1/36 (2.78%)  1 0/13 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders       
Cerebral Artery Embolism * 1  1/36 (2.78%)  1 0/13 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders       
Renal Failure Chronic * 1  1/36 (2.78%)  1 0/13 (0.00%)  0 0/2 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)J
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Stopped at End of Treatment Period 1 Continued at 15 mg/Day Dose Escalated to 30 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/36 (83.33%)      12/13 (92.31%)      2/2 (100.00%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Cardiac disorders       
Cardiac Failure * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Ventricular Extrasystoles * 1  0/36 (0.00%)  0 2/13 (15.38%)  2 0/2 (0.00%)  0
Ventricular Tachycardia * 1  4/36 (11.11%)  4 0/13 (0.00%)  0 1/2 (50.00%)  1
Gastrointestinal disorders       
Abdominal Pain * 1  1/36 (2.78%)  1 1/13 (7.69%)  2 0/2 (0.00%)  0
Constipation * 1  5/36 (13.89%)  5 0/13 (0.00%)  0 0/2 (0.00%)  0
Diarrhoea * 1  1/36 (2.78%)  1 2/13 (15.38%)  2 0/2 (0.00%)  0
General disorders       
Chest Pain * 1  2/36 (5.56%)  2 0/13 (0.00%)  0 0/2 (0.00%)  0
Pain  2  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Thirst * 1  14/36 (38.89%)  14 6/13 (46.15%)  6 0/2 (0.00%)  0
Infections and infestations       
Nasopharyngitis * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Urinary Tract Infection * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Investigations       
Alanine Aminotransferase Increased * 1  3/36 (8.33%)  3 0/13 (0.00%)  0 0/2 (0.00%)  0
Aspartate Aminotransferase Increased * 1  3/36 (8.33%)  3 1/13 (7.69%)  1 0/2 (0.00%)  0
Blood Alkaline Phosphatase Increased * 1  0/36 (0.00%)  0 0/13 (0.00%)  0 1/2 (50.00%)  1
Blood Creatinine Increased * 1  4/36 (11.11%)  4 4/13 (30.77%)  4 1/2 (50.00%)  1
Blood Glucose Increased * 1  4/36 (11.11%)  4 4/13 (30.77%)  4 0/2 (0.00%)  0
Blood Lactate Dehydrogenase Increased * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Blood Potassium Increased * 1  3/36 (8.33%)  3 3/13 (23.08%)  3 0/2 (0.00%)  0
Blood Urea Increased * 1  6/36 (16.67%)  6 4/13 (30.77%)  4 1/2 (50.00%)  1
Blood Uric Acid Increased * 1  6/36 (16.67%)  6 4/13 (30.77%)  5 1/2 (50.00%)  1
Blood Urine Present * 1  1/36 (2.78%)  1 1/13 (7.69%)  1 0/2 (0.00%)  0
Glucose Urine Present * 1  1/36 (2.78%)  1 1/13 (7.69%)  1 0/2 (0.00%)  0
White Blood Cell Count Increased * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Metabolism and nutrition disorders       
Hyperkalaemia * 1  1/36 (2.78%)  1 1/13 (7.69%)  1 0/2 (0.00%)  0
Hyperlipidaemia * 1  0/36 (0.00%)  0 0/13 (0.00%)  0 1/2 (50.00%)  1
Hyponatraemia * 1  1/36 (2.78%)  1 2/13 (15.38%)  2 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Myalgia * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Psychiatric disorders       
Insomnia * 1  0/36 (0.00%)  0 2/13 (15.38%)  2 0/2 (0.00%)  0
Renal and urinary disorders       
Pollakiuria * 1  2/36 (5.56%)  2 1/13 (7.69%)  1 0/2 (0.00%)  0
Renal Impairment * 1  1/36 (2.78%)  1 1/13 (7.69%)  1 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Epistaxis * 1  1/36 (2.78%)  1 3/13 (23.08%)  3 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders       
Decubitus Ulcer * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Haemorrhage Subcutaneous * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Pruritus * 1  2/36 (5.56%)  2 1/13 (7.69%)  1 0/2 (0.00%)  0
Purpura * 1  0/36 (0.00%)  0 1/13 (7.69%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)J
2
Term from vocabulary, MedDRA (11.0)
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
Name/Title: Director of Clinical Trials
Organization: Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7314
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00544869     History of Changes
Other Study ID Numbers: 156-06-006
First Submitted: October 15, 2007
First Posted: October 16, 2007
Results First Submitted: November 5, 2013
Results First Posted: January 30, 2014
Last Update Posted: January 30, 2014