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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 27, 2008
Last updated: April 2, 2008
Last verified: March 2008
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.

Condition Intervention Phase
Drug: Doxazosin mysylate GITS
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in the maximum urinary flow rate (Qmax) from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in the International Prostate Symptom Score (IPSS) total score from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the International Prostate Symptom Score (IPSS) total score from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in the maximum urinary flow rate (Qmax) from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in the quality of life (QoL) assessment index score from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: November 2003
Study Completion Date: January 2005
Arms Assigned Interventions
Experimental: A 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.


Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   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 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00648323

Pfizer Investigational Site
Kaohsiung, Taiwan, 813
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Pfizer Investigational Site
Taoyuan, Taiwan
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00648323     History of Changes
Other Study ID Numbers: A0351063 
Study First Received: March 27, 2008
Last Updated: April 2, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by Pfizer:
Benign Prostate Hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Genital Diseases, Male
Prostatic Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016