Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
tolterodine · 1 trial · 1 indication
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...
Tolterodine is used for overactive bladder. It is a small molecule being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development. The drug is being studied in patients with overactive bladder, a condition characterized by a frequent and urgent need to urinate.
Tolterodine is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's effects in patients with overactive bladder. As of the latest data, tolterodine is in Phase 1 development.
Tolterodine is in Phase 1 clinical development. It is an investigational drug being studied for overactive bladder. The drug has completed one Phase 1 trial, and it is not yet approved by regulatory authorities. Further clinical studies are needed to evaluate its safety and efficacy.
Tolterodine has one completed clinical trial registered under NCT00768521, titled "A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)." This Phase 1 trial enrolled 20 female patients aged 40 years and older with overactive bladder. The trial was randomized, double-blind, and controlled.
Tolterodine is the active ingredient in the drug product, and the clinical trial for overactive bladder specifically studied tolterodine tartrate, a salt form of the drug. The trial title references tolterodine tartrate, indicating that the tartrate salt is the formulation being tested in clinical development.