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

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ClinicalTrials.gov Identifier: NCT00648323
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : April 7, 2008
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Prostate Drug: Doxazosin mysylate GITS Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2003
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in the maximum urinary flow rate (Qmax) from baseline [ Time Frame: 8 weeks ]
  2. Change in the International Prostate Symptom Score (IPSS) total score from baseline [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in the International Prostate Symptom Score (IPSS) total score from baseline [ Time Frame: 4 weeks ]
  2. Change in the maximum urinary flow rate (Qmax) from baseline [ Time Frame: 4 weeks ]
  3. Change in the quality of life (QoL) assessment index score from baseline [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00648323


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00648323     History of Changes
Other Study ID Numbers: A0351063
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: April 7, 2008
Last Verified: March 2008

Keywords provided by Pfizer:
Benign Prostate Hyperplasia

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