A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

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Brief Title

A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

Official Title

A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

Brief Summary

      ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral
      administration of OPC-41061 at doses of 15 mg twice daily (morning and evening).
      Administration will be continued until the time of manufacturing and distribution approval of
      OPC-41061 for ADPKD in Japan.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Total Kidney Volume


Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

OPC-41061

Study Arms / Comparison Groups

 OPC-41061
Description:  Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

13

Start Date

November 2009

Completion Date

July 2014

Primary Completion Date

July 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who completed 3-year repeated administrations and the follow-up observation
             or those who were withdrawn from the study due to reasons other than occurrence of
             adverse events (based on the judgment of either the subject or the
             investigator/subinvestigator) in the preceding study (156-05-002)

          -  Patients in whom adverse events occurring in study 156-05-002 were resolved or became
             stable and do not require further follow-up.

        Exclusion Criteria:

          -  Patients with eGFR of less than 15 mL/min/1.73 m2

          -  Patients with any of the following complications:

               -  Uncontrolled hypertension

               -  Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg.
                  cirrhosis)

          -  Patients with any of the following complications or history thereof:

               -  Clinically significant drug allergies (anaphylaxis) or hypersensitivity
                  (especially, hypersensitivity to benzazepine derivatives or suspected
                  hypersensitivity

               -  Inability to personally give consent due to a mental illness
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01022424

Organization ID

156-09-003

Secondary IDs

JapicCTI-090948

Responsible Party

Sponsor

Study Sponsor

Otsuka Pharmaceutical Co., Ltd.


Study Sponsor

, , 


Verification Date

August 2018