overactive bladder
Conditions
Interventions
Product Name: fesoterodine hydrogen fumarate
Product Code: SPM 8272
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: fesoterodine
CAS Number: 286930-03-8
Current Sponsor code: SPM 8272
Oth
Sponsors
Schwarz Biosciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. 2. Subject is willing and able to comply with all trial requirements. 3. Subject has completed the full 12 week treatment period after randomization in trial SP583 as scheduled without meeting discontinuation criteria and with no adverse events that would, in the opinion of the investigator, jeopardize the well-being of the subject if treatment is continued. 4. Subject has, in the opinion of the investigator, successfully completed the diaries in trial SP583. 5. If female, a woman of child-bearing potential has a negative urine pregnancy test. 6. If female, a woman of child-bearing potential is using contraception (eg, barrier method, hormonal) or is not heterosexually active. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject is experiencing an ongoing serious adverse event assessed as being related to trial medication or is experiencing a serious adverse event that is still not assessable. 2. The subject has an intercurrent illness that requires termination of treatment. 3. The subject has a residual urine >200mL. 4. The automatic reading of the ECG shows an absolute QTc value >500msec or an individual increase of >60msec relative to baseline measurement of SP583 (the mean of the two manual central ECG laboratory QTc values recorded at Visit 2 of trial SP583).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to receive long-term data on safety and tolerability;Secondary Objective: to receive 1 year data on efficacy;Primary end point(s): •Observation and assessment of adverse events •Duration on therapy | — |
Countries
Italy, Spain
Outcome results
None listed