Status:
COMPLETED
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
Lead Sponsor:
Health Ever Bio-Tech Co., Ltd.
Conditions:
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
PHASE3
Brief Summary
This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for this ...
Detailed Description
This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-...
Eligibility Criteria
Inclusion
- Subject has completed 12 weeks of treatment under the protocol MCS-2-TWN-a.
- Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.
Exclusion
- Subject has severe LUTS at the last visit under the protocol MCS-2-TWN-a.
- Subject is considered ineligible for the study by the investigator(s).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01002274
Start Date
August 1 2010
End Date
June 1 2014
Last Update
November 11 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan