Urinary Bladder, Overactive Clinical Trial
Official title:
A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder
The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active bladder.
This is a multinational, multicenter, double-blind, double-dummy,
randomized, parallel group, placebo and active controlled phase II proof-of concept study.
Patients are enrolled into a single-blind, 2-week placebo run in
period after which they are randomized to 4 weeks of double-blind
treatment with YM178 (low dose and high dose), placebo or tolterodine. Subsequently patients
will be followed for an additional 2 weeks
with single-blind placebo treatment. There are 6 visits in total: visit 1 at
enrolment, visit 2 (baseline) after the 2-week placebo run-in, visits 3, 4 and 5
after 1, 2 and 4 weeks of double-blind treatment respectively, and visit 6
after a 2-week follow-up.
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