A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01003886
First received: October 28, 2009
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

This study aims to assess the safety, tolerability and efficacy of Doxazosin GITS in Filipino patients diagnosed with Benign Prostatic Hyperplasia (BPH) under the usual clinical care setting.


Condition Intervention
Prostatic Hyperplasia
Drug: Doxazosin mesylate GITS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance Study To Determine The Safety, Tolerability And Effectiveness Of Doxazosin Mesylate GITS Among Filipino Adult Males With Benign Prostatic Hyperplasia (BPH)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 13 (7 days after last dose) ] [ Designated as safety issue: Yes ]
    Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.


Secondary Outcome Measures:
  • Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    The IPSS total score is obtained by combining the scores of the responses to 1 through 7 component questions all of which were on a 6 point likert scale. Each question is scored from 0-5 for an IPSS range of 0-35 points where 0 = best possible score to 35 = worst possible score.

  • Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    The IPSS QoL Score is obtained by assessment of a single QoL question on a 7-point likert scale which was scored on a scale of 0-6 where 0 = best possible score to 6 = worst possible score.

  • Change From Baseline in Systolic BP at Week 4 and Week 12 [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: Yes ]
    Values at Week 4 and Week 12 minus value at baseline.

  • Change From Baseline in Diastolic BP at Week 4 and Week 12 [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: Yes ]
    Values at Week 4 and Week 12 minus value at baseline.

  • Percentage of Participants With Postural Hypotension [ Time Frame: Baseline up to Week 13 (7 days after last dose) ] [ Designated as safety issue: Yes ]
    Postural or orthostatic hypotension is a medical condition where blood pressure falls rapidly after the body changes position most commonly occurring after standing up after sitting for long periods of time.


Enrollment: 989
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Open Label
Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS
Drug: Doxazosin mesylate GITS
Doxazosin mesylate GITS 4mg to 8mg once daily
Other Name: Alfadil XL

Detailed Description:

This is an open label study. All patients prescribed with Doxazosin GITS can be enrolled in this study.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Filipino adult males diagnosed with Benign Prostatic Hyperplasia (BPH) and prescribed with Doxazosin mesylate GITS

Criteria

Inclusion Criteria:

  • Subjects that will be included must be consistent with the approved label indication of Doxazosin mesylate GITS in the Philippines, which includes adult male diagnosed with BPH, and who are prescribed with Doxazosin mesylate GITS.

Exclusion Criteria:

  • Subjects with condition that are contraindicated with Doxazosin mesylate GITS based on the approved labeling in the Philippines.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003886

  Show 73 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01003886     History of Changes
Other Study ID Numbers: A0351068
Study First Received: October 28, 2009
Results First Received: September 19, 2011
Last Updated: September 19, 2011
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Pfizer:
post marketing surveillance Filipino benign prostatic hyperplasia BPH Doxazosin GITS

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
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 September 18, 2014