Status:
COMPLETED
Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Prostate
Eligibility:
MALE
50-80 years
Phase:
PHASE4
Brief Summary
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination \[DRE\] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study.
- Exclusion criteria include but not limited to:
- Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months
- Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00648323
Start Date
November 1 2003
End Date
January 1 2005
Last Update
January 29 2021
Active Locations (4)
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1
Pfizer Investigational Site
Kaohsiung City, Taiwan, 813
2
Pfizer Investigational Site
Taichung, Taiwan
3
Pfizer Investigational Site
Taipei, Taiwan
4
Pfizer Investigational Site
Taoyuan District, Taiwan