Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-29 @ 3:56 PM
Study NCT ID:
NCT01604928
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2012-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Test the Efficacy and Safety of YM178 in Subjects With Symptoms of Overactive Bladder
Sponsor:
Astellas Pharma Europe B.V.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Blossom
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: