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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00648323
First received: March 27, 2008
Last updated: April 2, 2008
Last verified: March 2008
History of Changes
  Purpose

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
Prostate
 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

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
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Doxazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013