- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00648323
Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
Study Overview
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 813
- Pfizer Investigational Site
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Taichung, Taiwan
- Pfizer Investigational Site
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Taipei, Taiwan
- Pfizer Investigational Site
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Taoyuan, Taiwan
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the maximum urinary flow rate (Qmax) from baseline
Time Frame: 8 weeks
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8 weeks
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Change in the International Prostate Symptom Score (IPSS) total score from baseline
Time Frame: 8 weeks
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Time Frame: 4 weeks
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4 weeks
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Change in the maximum urinary flow rate (Qmax) from baseline
Time Frame: 4 weeks
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4 weeks
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Change in the quality of life (QoL) assessment index score from baseline
Time Frame: 8 weeks
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
March 27, 2008
First Submitted That Met QC Criteria
March 27, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Prostatic Diseases
- Prostatic Hyperplasia
- Hyperplasia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Doxazosin
Other Study ID Numbers
- A0351063
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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