Trials / Completed
CompletedNCT02485067
Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB
Multicenter, Randomized, Double-blind, Parallel, Active Control, Phase III Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With Overactive Bladder Including an Open-label, Extension Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 384 (actual)
- Sponsor
- SK Chemicals Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to assess the efficacy and safety of THVD-201(Combination of tolterodine and pilocarpine) in patients with Overactive bladder during the period of treatment, 12 weeks. This study also includes an open label extension period of an additional 12 weeks following the treatment to assess long-term efficacy and safety of THVD-201 in patients with Overactive bladder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | THVD-201 | Combination of Tolterodine 2mg and Pilocarpine 9mg |
| DRUG | Placebo(For THVD-201) | |
| DRUG | Detrusitol 2mg tablet | Tolterodine 2mg |
| DRUG | Placebo(For Detrusitol 2mg tablet) |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2016-07-01
- Completion
- 2016-09-01
- First posted
- 2015-06-30
- Last updated
- 2017-01-12
Locations
16 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02485067. Inclusion in this directory is not an endorsement.