Status:
COMPLETED
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
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
35-75 years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00645034
Start Date
November 1 2002
End Date
July 1 2003
Last Update
February 1 2021
Active Locations (2)
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1
Pfizer Investigational Site
Laguna Woods, California, United States, 92653
2
Pfizer Investigational Site
Newport Beach, California, United States, 92660