Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate
Intervention: Doxazosin mysylate GITS (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The primary objectives were to determine the efficacy and safety of the GITS formulation of
Doxazosin in Taiwanese patients with prostate enlargement.
Clinical Details
Official title: A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in the maximum urinary flow rate (Qmax) from baselineChange in the International Prostate Symptom Score (IPSS) total score from baseline
Secondary outcome: Change in the International Prostate Symptom Score (IPSS) total score from baselineChange in the maximum urinary flow rate (Qmax) from baseline Change in the quality of life (QoL) assessment index score from baseline
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, Kaohsiung 813, Taiwan
Pfizer Investigational Site, Taichung, Taiwan
Pfizer Investigational Site, Taipei, Taiwan
Pfizer Investigational Site, Taoyuan, Taiwan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2003
Last updated: April 2, 2008
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