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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate

Intervention: Doxazosin mysylate GITS (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in the maximum urinary flow rate (Qmax) from baseline

Change in the International Prostate Symptom Score (IPSS) total score from baseline

Secondary outcome:

Change in the International Prostate Symptom Score (IPSS) total score from baseline

Change in the maximum urinary flow rate (Qmax) from baseline

Change in the quality of life (QoL) assessment index score from baseline

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Male.

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.

Locations and Contacts

Pfizer Investigational Site, Kaohsiung 813, Taiwan

Pfizer Investigational Site, Taichung, Taiwan

Pfizer Investigational Site, Taipei, Taiwan

Pfizer Investigational Site, Taoyuan, Taiwan

Additional Information

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

Starting date: November 2003
Last updated: April 2, 2008

Page last updated: August 23, 2015

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