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Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB

NCT02485067 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2017-01-12

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyu Sung Lee · Samsung Medical Center (SMC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-07-31
Completion
2016-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485067 on ClinicalTrials.gov