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NCT00648323 Clinical Trial

Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement

Prostate Clinical Trial

Official title:
A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Doxazosin mysylate GITS
Subjects initiated on 4 mg doxazosin GITS once daily at Visit 1 for four weeks. At Visit 2 (Week 4) increased to 8 mg Doxazosin GITS if efficacy response criteria not met.

Locations
Country Name City State
Taiwan Pfizer Investigational Site Kaohsiung
Taiwan Pfizer Investigational Site Taichung
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome
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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