Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01857622
First received: May 16, 2013
Last updated: January 15, 2015
Last verified: January 2015
Results First Received: January 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Non-valvular Atrial Fibrillation
Interventions: Drug: DU-176b 15mg
Drug: DU-176b 30mg
Drug: DU-176b 60mg

  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
SRI 15mg

Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.

DU-176b 15mg: oral DU-176b 15mg once daily

Normal/MiRI Low-dose Group

Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.

DU-176b 30mg: oral DU-176b 30mg once daily

Normal/MiRI High-dose Group

Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.

DU-176b 60mg: oral DU-176b 60mg once daily


Participant Flow:   Overall Study
    SRI 15mg     Normal/MiRI Low-dose Group     Normal/MiRI High-dose Group  
STARTED     50     22     21  
COMPLETED     39     21     19  
NOT COMPLETED     11     1     2  
Adverse Event                 5                 0                 2  
Physician Decision                 1                 0                 0  
Protocol Violation                 4                 1                 0  
Withdrawal by Subject                 1                 0                 0  



  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.
No text entered.

Reporting Groups
  Description
SRI 15mg

Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.

DU-176b 15mg: oral DU-176b 15mg once daily

Normal/MiRI Low-dose Group

Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.

DU-176b 30mg: oral DU-176b 30mg once daily

Normal/MiRI High-dose Group

Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.

DU-176b 60mg: oral DU-176b 60mg once daily

Total Total of all reporting groups

Baseline Measures
    SRI 15mg     Normal/MiRI Low-dose Group     Normal/MiRI High-dose Group     Total  
Number of Participants  
[units: participants]
  50     22     21     93  
Age  
[units: years]
Mean (Standard Deviation)
  80.9  (6.04)     68.0  (8.91)     72.2  (4.58)     75.9  (8.57)  
Gender  
[units: participants]
       
Female     22     4     7     33  
Male     28     18     14     60  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     50     22     21     93  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     0     0  
White     0     0     0     0  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
Japan     50     22     21     93  



  Outcome Measures

1.  Primary:   Incidence of Any Adjudicated Bleeding Events   [ Time Frame: 3 months ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kenichi Sakakura, Manager
Organization: Daiichi Sankyo.,LTD
phone: 81-90-1885-0271
e-mail: sakakura.kenichi.ef@daiichisankyo.co.jp


No publications provided


Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01857622     History of Changes
Other Study ID Numbers: DU176b-B-J307
Study First Received: May 16, 2013
Results First Received: January 15, 2015
Last Updated: January 15, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency