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
• Status: Completed
• Phase: Phase 4
• Start date: November 2003
• Est. completion date: January 2005

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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
• 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.

Related Conditions & MeSH terms

• Hyperplasia
• Prostate
• Prostatic Hyperplasia

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

External Links

•   To obtain contact information for a study center near you, click here.