Official Title: “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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary Measures

• Change in the maximum urinary flow rate (Qmax) from baseline
  • Time Frame: 8 weeks
    Safety Issue?: No
• Change in the International Prostate Symptom Score (IPSS) total score from baseline
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Change in the International Prostate Symptom Score (IPSS) total score from baseline
  • Time Frame: 4 weeks
    Safety Issue?: No
• Change in the maximum urinary flow rate (Qmax) from baseline
  • Time Frame: 4 weeks
    Safety Issue?: No
• Change in the quality of life (QoL) assessment index score from baseline
  • Time Frame: 8 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00648323

Study ID Number: A0351063

ClinicalTrials.gov Identifier: NCT00648323

Health Authority: Taiwan: Department of Health

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting: