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

NCT01003886 | Completed Results

• 1 other identifier: A0351068
• Study Type: observational
• Target: 989
• Locations: 1 country
• Sites: 67

Brief Summary

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.

Conditions

Prostatic Hyperplasia

Keywords

post marketing surveillance Filipino benign prostatic hyperplasia BPH Doxazosin GITS

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

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

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

Secondary Outcomes (5)

• Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12

  Baseline, Week 4 and Week 12

• Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12

  Baseline, Week 4 and Week 12

• Change From Baseline in Systolic BP at Week 4 and Week 12

  Baseline through Week 12

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

  Baseline through Week 12

• Percentage of Participants With Postural Hypotension

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

Study Arms (1)

Open Label

Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS

Drug: Doxazosin mesylate GITS

Interventions

Doxazosin mesylate GITS DRUG

Doxazosin mesylate GITS 4mg to 8mg once daily

Also known as: Alfadil XL

Open Label

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Subjects with condition that are contraindicated with Doxazosin mesylate GITS based on the approved labeling in the Philippines.

Sponsors & Collaborators

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

Study Sites (67)

Pfizer Investigational Site

Butuan, Agusan Del Norte, Philippines

Location

Pfizer Investigational Site

San Juan City, Batangas, Philippines

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Pfizer Investigational Site

Tagbilaran City, Bohol, Philippines

Location

Pfizer Investigational Site

Quezon City, Diliman, Philippines

Location

Pfizer Investigational Site

City of San Fernando, La Union, Philippines

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Pfizer Investigational Site

Ermita, Manila, 1000, Philippines

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Pfizer Investigational Site

Tondo, Manila, 1000, Philippines

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Pfizer Investigational Site

Diliman, Quezon City, National Capital Region, 1101, Philippines

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Pfizer Investigational Site

Pasig, National Capital Region, 1605, Philippines

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Pfizer Investigational Site

Angeles City, Pampanga, Philippines

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Pfizer Investigational Site

Angeles, Philippines

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Pfizer Investigational Site

Angeles City, Philippines

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Pfizer Investigational Site

Bacolod City, Philippines

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Pfizer Investigational Site

Baguio City, Philippines

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Pfizer Investigational Site

Bohol, Philippines

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Pfizer Investigational Site

Bulacan, Philippines

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Pfizer Investigational Site

Butuan, Philippines

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Pfizer Investigational Site

Cagayan de Oro, Philippines

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Pfizer Investigational Site

Cebu, Philippines

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Pfizer Investigational Site

Cebu City, 6000, Philippines

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Pfizer Investigational Site

Cebu City, Philippines

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Pfizer Investigational Site

City of Muntinlupa, Philippines

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Pfizer Investigational Site

Davao City, Philippines

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Pfizer Investigational Site

Gallares City, Philippines

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Pfizer Investigational Site

General Santos, Philippines

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Pfizer Investigational Site

Iligan City, Philippines

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Pfizer Investigational Site

Ilocos Norte, Philippines

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Pfizer Investigational Site

Kalibo, Philippines

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Pfizer Investigational Site

Kalibo Aklan, Philippines

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Pfizer Investigational Site

La Union, Philippines

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Pfizer Investigational Site

Laguna, Philippines

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Pfizer Investigational Site

Laoag, Philippines

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Pfizer Investigational Site

Lingayen, Pangasinan, Philippines

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Pfizer Investigational Site

Makati City, Philippines

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Pfizer Investigational Site

Malabon, Philippines

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Pfizer Investigational Site

Manadaluyong, Philippines

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Pfizer Investigational Site

Mandaluyong, Philippines

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Pfizer Investigational Site

Mandaue City, Philippines

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Pfizer Investigational Site

Manila, 1000, Philippines

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Pfizer Investigational Site

Manila, Philippines

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Pfizer Investigational Site

Marikina City, Philippines

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Pfizer Investigational Site

Mindanaw, Philippines

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Pfizer Investigational Site

Nueva Ecija, Philippines

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Pfizer Investigational Site

Nueva Vizcaya, Philippines

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Pfizer Investigational Site

Ozamiz, Philippines

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Pfizer Investigational Site

Pampanga, Philippines

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Pfizer Investigational Site

Pasig, Philippines

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Pfizer Investigational Site

Philippines, Philippines

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Pfizer Investigational Site

Quezon, Philippines

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Pfizer Investigational Site

Quezon City, 1100, Philippines

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Pfizer Investigational Site

Quezon City, 1102, Philippines

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Pfizer Investigational Site

Quezon City, 1109, Philippines

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Pfizer Investigational Site

Quezon City, Philippines

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Pfizer Investigational Site

Rizal, Philippines

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Pfizer Investigational Site

San Jose, Philippines

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Pfizer Investigational Site

Surigao City, Philippines

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Pfizer Investigational Site

Tacloban City, Philippines

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Pfizer Investigational Site

Tagbilaran City, 6300, Philippines

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Pfizer Investigational Site

Tagbilaran City, Philippines

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Pfizer Investigational Site

Tagum, Philippines

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Pfizer Investigational Site

Tarlac City, 2300, Philippines

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Pfizer Investigational Site

Tarlac City, Philippines

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Pfizer Investigational Site

Tuguegarao City, Philippines

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Pfizer Investigational Site

Valenzuela, Philippines

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Pfizer Investigational Site

Vigan, Philippines

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Pfizer Investigational Site

Visayas, Philippines

Location

Pfizer Investigational Site

West Fairview, Quezon City, 1100, Philippines

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 28, 2021
• Results First Posted: October 28, 2011

Record last verified: 2021-01

Locations

PH (67)