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Completed

NCT Number: NCT00648323

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

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

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Key information

Conditions

Prostate Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxazosin mysylate GITS

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia

Important dates

Study start
2003
Study completion
2005
First posted
Apr 1, 2008
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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