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Completed

NCT Number: NCT01003886

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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Pfizer Investigational Site, Butuan, Agusan Del Norte, Philippines

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Doxazosin mesylate GITS

Drug

Doxazosin mesylate GITS 4mg to 8mg once daily

Other names: Alfadil XL

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Baseline up to Week 13 (7 days after last dose)

    Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. Change From Baseline in Systolic BP at Week 4 and Week 12

    Time frame: Baseline through Week 12

    Values at Week 4 and Week 12 minus value at baseline.

  4. Change From Baseline in Diastolic BP at Week 4 and Week 12

    Time frame: Baseline through Week 12

    Values at Week 4 and Week 12 minus value at baseline.

  5. Percentage of Participants With Postural Hypotension

    Time frame: Baseline up to Week 13 (7 days after last dose)

    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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2009
Registry last updated
Jan 28, 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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