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NCT01003405 Clinical Trial

Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder

Overactive Bladder Clinical Trial

Official title:
A Open-label, Long-term Extension Study of KUC-7483 in Patients With Overactive Bladder

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01003405
Other study ID # KUC1302
Secondary ID
Status Withdrawn
Phase Phase 3
First received October 27, 2009
Last updated July 25, 2010

Study information
Verified date July 2010
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients with overactive bladder.

Recruitment information / eligibility
Status Withdrawn
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients who have successfully completed the Phase III double-blind study.

Exclusion Criteria:

- Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• KUC-7483

Locations
Country Name City State
Japan Japan Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu

Sponsors (1)
Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The long-term safety of KUC-7483 for the treatment of overactive bladder. 52 weeks Yes
Secondary The long-term efficacy of KUC-7483 for the treatment of overactive bladder. 52 weeks No
See also
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