NCT00648323

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

First QC Date

March 27, 2008

Last Update Submit

January 26, 2021

Conditions

Prostate

Keywords

Benign Prostate Hyperplasia

Outcome Measures

Primary Outcomes (2)

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

    8 weeks

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

    8 weeks

Secondary Outcomes (3)

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

    4 weeks

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

    4 weeks

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

    8 weeks

Study Arms (1)

A

EXPERIMENTAL
Drug: Doxazosin mysylate GITS

Interventions

Doxazosin mysylate GITSDRUG

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.

A

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Kaohsiung City, 813, Taiwan

Location

Pfizer Investigational Site

Taichung, Taiwan

Location

Pfizer Investigational Site

Taipei, Taiwan

Location

Pfizer Investigational Site

Taoyuan District, Taiwan

Location

Related Links

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

November 1, 2003

Study Completion

January 1, 2005

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

TW(4)