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A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

2014-07-23 21:13:32 | BioPortfolio

Summary

The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

Description

This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test.

The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Urinary Bladder, Overactive

Intervention

YM178, Placebo, tolterodine

Location

Chubu
Japan

Status

Completed

Source

Astellas Pharma Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:32-0400

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A Study of YM178 in Subjects With Symptoms of Overactive Bladder

This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.

Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder

The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and compare the efficacy and safety with active comparator in patients with symptoms o...

A Study of YM178 in Patients With Symptomatic Overactive Bladder

Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients

The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.

Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Patients With Symptoms of Overactive Bladder

The study is intended to test the efficacy, safety and tolerability of two doses of YM178 against placebo to treat patients with symptoms of overactive bladder

PubMed Articles [2505 Associated PubMed Articles listed on BioPortfolio]

Simultaneous determination of tolterodine and its two metabolites, 5-hydroxymethyltolterodine and N-dealkyltolterodine in human plasma using LC-MS/MS and its application to a pharmacokinetic study.

Tolterodine is a nonselective muscarinic antagonist that is indicated for the overactive urinary bladder and other urinary difficulties. We developed and validated a simple, rapid and sensitive high-p...

Clinical features and association of bladder ultrasound findings and uroflowmetry with healing period of overactive bladder in children.

Overactive bladder (OAB) is a symptomatic syndrome defined by urinary urgency, usually accompanied by increased urination frequency and nocturia, with or without urinary incontinence. The prevalence o...

Improving Clinical Outcomes for Women with Overactive Bladder and Urinary Retention Symptoms: A Comparison of Motor Response Voltages (1 - 9) during Stage 1 Sacral Neuromodulation.

To assess whether the utilization of a motor response 4 volts in patients with overactive bladder or urinary retention.

A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints.

Overactive bladder is a chronic condition affecting lower urinary tract function that has a significant negative impact on QoL.

An Integrative Review of Current Research on the Role of the Female Urinary Microbiota in Overactive Bladder Symptoms.

This integrative review explores current evidence on microbiota of the female urinary tract as it relates to overactive bladder (OAB) symptoms. Six articles were identified for review. Findings sugges...

Medical and Biotech [MESH] Definitions

Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.

An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE.

Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.

A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.

An abnormal passage in the URINARY BLADDER or between the bladder and any surrounding organ.

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