- ICH GCP
- US Clinical Trials Registry
- 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
January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Laguna Woods, California, United States, 92653
- Pfizer Investigational Site
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Newport Beach, California, United States, 92660
- Pfizer Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Arm 2
|
placebo by mouth as a single dose
|
Active Comparator: Arm 1
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sildenafil 100 mg by mouth as a single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacodynamic parameters of blood pressure and pulse rate
Time Frame: immediately predose, 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose
|
immediately predose, 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood samples for doxazosin pharmacokinetic parameters
Time Frame: time 0 (pre-dose), and at 1, 2, 3, 4, 6, and 8 hours post-dose
|
time 0 (pre-dose), and at 1, 2, 3, 4, 6, and 8 hours post-dose
|
Safety and toleration of simultaneously co-administering sildenafil and doxazosin.
Time Frame: continuous
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continuous
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
March 20, 2008
First Submitted That Met QC Criteria
March 26, 2008
First Posted (Estimate)
March 27, 2008
Study Record Updates
Last Update Posted (Actual)
February 1, 2021
Last Update Submitted That Met QC Criteria
January 28, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A1481163
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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