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NCT00645034 · ClinicalTrials.gov registry record · Phase 2

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 Phase 2 study of Benign Prostatic Hyperplasia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
2
Study locations

NCT00645034 is a Phase 2 study of Benign Prostatic Hyperplasia that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 20 participants, below the 551-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT00645034, a Phase 2 study of Benign Prostatic Hyperplasia, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
2
Study locations

Study 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.

Interventions

  • DRUG placebo
  • DRUG sildenafil

Study Locations (2)

California

  • Pfizer Investigational Site - Laguna Woods
  • Pfizer Investigational Site - Newport Beach

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2002-11
Est. Completion 2003-07
Phase Phase 2

What the Registry Record Tells You About NCT00645034

The ClinicalTrials.gov registry entry for NCT00645034 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 551-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (96% lower). The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00645034 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00645034 about?

NCT00645034 is a clinical study titled "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". 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 saf...

What is the current status of trial NCT00645034?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2002-11. Estimated completion is 2003-07.

What conditions does trial NCT00645034 study?

This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.

What interventions are being tested in trial NCT00645034?

The interventions under investigation include: placebo (DRUG), sildenafil (DRUG).

Who is sponsoring clinical trial NCT00645034?

This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00645034 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.