Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478881
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2007-05-24
Brief Title:
A Study To Assess If 10 mg Vardenafil BAY38-9456 Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Parallel Group Study of Vardenafil 10 mg Twice Daily to Assess the Effect on Urodynamics in Patients With Overactive Bladder Detrusor Overactivity
Status:
COMPLETED
Status Verified Date:
2014-11
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:
None
Brief Summary:
The purpose of this study is to assess if the study drug Vardenafil approved by Health Authorities is available on the market for treatment of erectile dysfunction has an effect on bladder function and micturition frequency The study drug is to be taken in the form of tablets twice a day one tablet in the morning and one tablet in the evening A non-active treatment placebo a sugar pill will be used as a comparator to see if the new study drug works better than no drug The timing of visits for the study is as follows the 1st visit screening visit at beginning of run-in-assessment with qualifying tests for patients electrocardiogram ECG safety laboratory and residual urine by ultrasonography a non-invasive examination using ultrasound for the assessment of the bladder 2nd visit randomization visit During visit this should be performed urodynamic measurements filling cystometry and pressure flow investigations ECG and safety laboratory 3rd visit safety visit takes place at two up to three weeks of randomized treatment 4th visit final visit-following test should be done urodynamic measurements filling cystometry and pressure flow investigations ECG safety laboratory and residual urine by ultrasonography A phone call 24 hours after visit 4 to assess any SAEs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-005145-11 | EUDRACT_NUMBER | None | None |