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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01003405
Recruitment Status : Withdrawn
First Posted : October 28, 2009
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: KUC-7483 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open-label, Long-term Extension Study of KUC-7483 in Patients With Overactive Bladder

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: KUC-7483 Drug: KUC-7483



Primary Outcome Measures :
  1. The long-term safety of KUC-7483 for the treatment of overactive bladder. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. The long-term efficacy of KUC-7483 for the treatment of overactive bladder. [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003405


Locations
Japan
Japan
Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Yasuhiro Omori Clinical Development Department, Kissei pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier: NCT01003405     History of Changes
Other Study ID Numbers: KUC1302
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Overactive bladder
Frequency
Micturition
Urgency
Urge urinary incontinence
OAB

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
p-Hydroxyamphetamine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics