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

NCT00645034 | Completed Phase 2

• 1 other identifier: A1481163
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamic parameters of blood pressure and pulse rate

  immediately predose, 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose

Secondary Outcomes (2)

• Blood samples for doxazosin pharmacokinetic parameters

  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.

  continuous

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: sildenafil

Arm 2

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

placebo by mouth as a single dose

Arm 2

sildenafil DRUG

sildenafil 100 mg by mouth as a single dose

Arm 1

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (2)

Pfizer Investigational Site

Laguna Woods, California, 92653, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 27, 2008
• Study Start: November 1, 2002
• Study Completion: July 1, 2003
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (2)