Prostate Clinical Trial
Official title:
A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia
NCT number | NCT00648323 |
Other study ID # | A0351063 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | November 2003 |
Est. completion date | January 2005 |
Verified date | January 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Pfizer Investigational Site | Kaohsiung | |
Taiwan | Pfizer Investigational Site | Taichung | |
Taiwan | Pfizer Investigational Site | Taipei | |
Taiwan | Pfizer Investigational Site | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the maximum urinary flow rate (Qmax) from baseline | 8 weeks | ||
Primary | Change in the International Prostate Symptom Score (IPSS) total score from baseline | 8 weeks | ||
Secondary | Change in the International Prostate Symptom Score (IPSS) total score from baseline | 4 weeks | ||
Secondary | Change in the maximum urinary flow rate (Qmax) from baseline | 4 weeks | ||
Secondary | Change in the quality of life (QoL) assessment index score from baseline | 8 weeks |
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