A Study to Investigate the Effects on Blood Pressure and Pulse Rate of a Single 100mg Dose of Sildenafil in Patients With Benign Prostatic Hyperplasia Who Are Being Treated With Doxazosin

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized, 2-way Crossover Study to Investigate the Hemodynamic Effects of a Single Dose of Sildenafil (100mg) in Subjects With Benign Prostatic Hyperplasia Being Treated With Doxazosin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645034
• Other study ID #: A1481163
• Status: Completed
• Phase: Phase 2
• Start date: November 2002
• Est. completion date: July 2003

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effects of a single dose of sildenafil (100 mg) or placebo on blood pressure and pulse rate in subjects taking doxazosin for benign prostatic hyperplasia (BPH). To investigate the pharmacokinetics of doxazosin when co-administered with sildenafil 100 mg, and to investigate the safety and toleration of sildenafil 100 mg when co-administered with doxazosin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients who weighed between 132 and 220 lb (60 and 100 kg) with benign prostatic hyperplasia (BPH)

• a total PSA (prostate specific antigen) measurement of less than or equal to 10 µg/L within the 12 months prior to screening, were currently on doxazosin treatment for BPH, had been treated with doxazosin for a minimum of 2 months prior to first dose of study medication, and had received a minimum of 4 mg doxazosin once daily (from doxazosin supplied for this study) for 2 weeks prior to the first dose of study medication.

Exclusion Criteria:

• subjects with a recent history (i.e. within 6 months prior to screening) of stroke or myocardial infarction

• subjects with severe cardiovascular disorders such as unstable angina or severe congestive heart failure

• subjects with known hereditary degenerative retinal disorders, such as retinitis pigmentosa

• subjects with a supine systolic/diastolic blood pressure of >170/100 mmHg or <100/60 mmHg either at screening or at the pre-dose measurements

• subjects receiving any other antihypertensive therapy other than doxazosin in the 3 weeks prior to the first dose of study medication.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• placebo
placebo by mouth as a single dose
• sildenafil
sildenafil 100 mg by mouth as a single dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Laguna Woods	California
United States	Pfizer Investigational Site	Newport Beach	California

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic parameters of blood pressure and pulse rate		immediately predose, 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose
Secondary	Blood samples for doxazosin pharmacokinetic parameters		time 0 (pre-dose), and at 1, 2, 3, 4, 6, and 8 hours post-dose
Secondary	Safety and toleration of simultaneously co-administering sildenafil and doxazosin.		continuous