CompletedNCT00648323Updated Jan 29, 2021

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

A Phase 4 interventional study of Doxazosin mysylate GITS in Prostate, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 4 sites in Taiwan. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 80
Allocation: Non-randomized
Ages: 50 Years to 80 Years
Sex: Male

Study summary

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

Conditions studied

Prostate

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Keywords

Benign Prostate Hyperplasia

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 80 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

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Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 80 Years
Sexes eligible: Male
Accepts healthy volunteers: No

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

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

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 80 participants (actual)

Study arms

Experimental
A
Drug: Doxazosin mysylate GITS

Interventions

DrugDoxazosin 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.

What researchers measure

Primary outcomes

Change in the maximum urinary flow rate (Qmax) from baseline
Time frame: 8 weeks
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Time frame: 8 weeks

Secondary outcomes

Change in the International Prostate Symptom Score (IPSS) total score from baseline
Time frame: 4 weeks
Change in the maximum urinary flow rate (Qmax) from baseline
Time frame: 4 weeks
Change in the quality of life (QoL) assessment index score from baseline
Time frame: 8 weeks

Study locations

4 sites

Pfizer Investigational Site
Kaohsiung, 813, Taiwan
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Pfizer Investigational Site
Taoyuan, Taiwan

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00648323
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
First posted: Apr 1, 2008
Start date: Nov 2003
Completion: Jan 2005
Last update: Jan 29, 2021

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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