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A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00234104
First received: October 4, 2005
Last updated: November 6, 2013
Last verified: November 2013
Results First Received: November 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Conditions: Heart Failure, Congestive
Edema
Intervention: Drug: OPC-41061(Tolvaptan)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Placebo     15 mg of OPC-41061     30 mg of OPC-41061     45 mg of OPC-41061  
STARTED     30     29     34     29  
COMPLETED     26     28     29     21  
NOT COMPLETED     4     1     5     8  
Adverse Event                 4                 0                 3                 5  
Protocol Violation                 0                 0                 0                 1  
Physician Decision                 0                 1                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
1 Subject of each arm were excluded form the analysis set because emergency codes were lost.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Placebo     15 mg of OPC-41061     30 mg of OPC-41061     45 mg of OPC-41061     Total  
Number of Participants  
[units: participants]
  29     28     33     28     118  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     11     10     11     14     46  
>=65 years     18     18     22     14     72  
Age  
[units: years]
Mean ± Standard Deviation
  67.9  ± 9.4     66.9  ± 9.6     66.4  ± 12.5     62.6  ± 12.5     66.0  ± 11.2  
Gender  
[units: participants]
         
Female     11     13     8     4     36  
Male     18     15     25     24     82  
Region of Enrollment  
[units: participants]
         
Japan     29     28     33     28     118  



  Outcome Measures

1.  Primary:   Body Weight   [ Time Frame: Baseline, at the time of final trial drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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


No publications provided


Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00234104     History of Changes
Other Study ID Numbers: 156-03-001, JapicCTI-050038
Study First Received: October 4, 2005
Results First Received: November 1, 2013
Last Updated: November 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare