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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645034
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 10, 2017
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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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: placebo Drug: sildenafil Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : November 2002
Actual Study Completion Date : July 2003

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Arm Intervention/treatment
Active Comparator: Arm 1 Drug: sildenafil
sildenafil 100 mg by mouth as a single dose

Placebo Comparator: Arm 2 Drug: placebo
placebo by mouth as a single dose

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Blood samples for doxazosin pharmacokinetic parameters [ Time Frame: time 0 (pre-dose), and at 1, 2, 3, 4, 6, and 8 hours post-dose ]
  2. Safety and toleration of simultaneously co-administering sildenafil and doxazosin. [ Time Frame: continuous ]

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00645034

United States, California
Pfizer Investigational Site
Laguna Woods, California, United States, 92653
Pfizer Investigational Site
Newport Beach, California, United States, 92660
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00645034     History of Changes
Other Study ID Numbers: A1481163
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs