Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00768521 | A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) | PHASE1 | COMPLETED | 20 | — | — | Sep 3, 2008 | Jan 19, 2009 | Feb 22, 2018 | - | — |
Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo |
| 2 | EXPERIMENTAL | Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd) |
| 3 | EXPERIMENTAL | Part II, Sequence 1: study drug crossing over to placebo |
| 4 | EXPERIMENTAL | Part II, Sequence 2: placebo crossing over to study drug |
| Name | Type | Description |
|---|---|---|
| tolterodine tartrate | DRUG | Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule |
| Comparator: Placebo to tolterodine tartrate | DRUG | Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule |
Inclusion Criteria: * Patient is a postmenopausal female 40 to 75 years of age * Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2 * Patient has a documented history of overactive bladder for at least 6 months prior to screening Exclusion Criteria: * Patient has stress or mixed i...