NCT00645034

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Male
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	placebo	placebo by mouth as a single dose
DRUG	sildenafil	sildenafil 100 mg by mouth as a single dose

Timeline

• Start date: 2002-11-01
• Completion: 2003-07-01
• First posted: 2008-03-27
• Last updated: 2021-02-01

Locations

2 sites across 1 country: United States