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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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Laguna Woods, California, 92653 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Benign Prostatic Hyperplasia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 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.

NCT00645034
Pfizer
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

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Benign Prostatic Hyperplasia
  • Drug: placebo
    placebo by mouth as a single dose
  • Drug: sildenafil
    sildenafil 100 mg by mouth as a single dose
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
  • Placebo Comparator: Arm 2
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2003
Not Provided

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.
Sexes Eligible for Study: Male
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00645034
A1481163
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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