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

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: placebo; Drug: sildenafil

• Registration Number: NCT00645034
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2003-07
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-26
• Study First Posted: 2008-03-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 2	placebo	-
Arm 1	sildenafil	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety and toleration of simultaneously co-administering sildenafil and doxazosin.	continuous
Blood samples for doxazosin pharmacokinetic parameters	time 0 (pre-dose), and at 1, 2, 3, 4, 6, and 8 hours post-dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Newport Beach, California, United States