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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

sildenafil

Intervention Type DRUG

sildenafil 100 mg by mouth as a single dose

Arm 2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo by mouth as a single dose

Interventions

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placebo

placebo by mouth as a single dose

Intervention Type DRUG

sildenafil

sildenafil 100 mg by mouth as a single dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No