Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

This study has been completed.
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc Identifier:
First received: September 13, 2005
Last updated: November 15, 2011
Last verified: October 2006

The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.

Condition Intervention Phase
Overactive Bladder
Drug: Solifenacin succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptoms of overactive bladder
  • Must be able to complete the micturition diary

Exclusion Criteria:

  • Pregnant or lactating
  • Clinically significant outflow obstruction
  • Significant post void residual urine
  • Significant stress incontinence
  • Urinary tract infection
  • Chronic inflammation
  • Bladder stones
  • Previous pelvic radiation therapy
  • Previous or current malignant disease of the pelvic organs
  • Uncontrolled narrow angle glaucoma
  • Urinary or gastric retention
  • Electrostimulation therapy
  • Bladder training
  • Diabetic neuropathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00189800

Korea, Republic of
Anyang, Korea, Republic of
Bucheon, Korea, Republic of
Busan, Korea, Republic of
Cheonan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Principal Investigator: Prof. Jeong Gu Lee Department of Urology, Korea University Anam Hospital
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00189800     History of Changes
Other Study ID Numbers: 90502/KOoTD01
Study First Received: September 13, 2005
Last Updated: November 15, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
randomized controlled trial
double-blind method

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents processed this record on March 03, 2015