Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 20
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacodynamic parameters of blood pressure and pulse rate
timeFrame: immediately predose, 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose
Secondary outcomes:
measure: Blood samples for doxazosin pharmacokinetic parameters
timeFrame: time 0 (pre-dose), and at 1, 2, 3, 4, 6, and 8 hours post-dose
measure: Safety and toleration of simultaneously co-administering sildenafil and doxazosin.
timeFrame: continuous
Other outcomes:
Locations:
city: Laguna Woods
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: