Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
- Registration Number
- NCT00648323
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Doxazosin mysylate GITS -
- Primary Outcome Measures
Name Time Method Change in the maximum urinary flow rate (Qmax) from baseline 8 weeks Change in the International Prostate Symptom Score (IPSS) total score from baseline 8 weeks
- Secondary Outcome Measures
Name Time Method Change in the International Prostate Symptom Score (IPSS) total score from baseline 4 weeks Change in the maximum urinary flow rate (Qmax) from baseline 4 weeks Change in the quality of life (QoL) assessment index score from baseline 8 weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Taoyuan, Taiwan