Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS

June 14, 2011 updated by: Hospital Authority, Hong Kong

Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS for the Treatment of Benign Prostatic Hyperplasia

The purpose of this study is to investigate the interaction between doxazosin GITS and vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with both ED and BPH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • China
      • Hong Kong, China
        • Prince of Wales Hospital

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 50 to 80 years old

  • Clinically diagnosed to have lower urinary tract symptoms secondary to BPH:

    1. Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) >=8
    2. Detectable prostatic enlargement determined by Digital Rectum Examination (DRE)
    3. Urinary flow between 5 to 15ml/second in a total void volume >=150mL
  • Currently on regular doxazosin GITS once-daily for at least 4 weeks without clinically significant side effects
  • Complaints of erectile dysfunction with Erectile Function domain (EF) of the International Index of Erectile Function (IIEF) score <= 21

Exclusion Criteria:

  • Congestive heart failure, unstable angina, arrhythmia, myocardial infraction
  • Hypertension or on any antihypertensive agents
  • Take nitrate and medication contradicted to vardenafil
  • Uncontrolled or poorly controlled diabetes mellitus
  • Intolerance or contra-indicated for the use of vardenafil
  • Hepatic disorder

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean maximal change of the standing systolic blood pressure (SBP) from half hour prior to till six hour after administration of the drug (baseline) with vardenafil administration versus placebo
Time Frame: From half hour prior to till six hour after administration of the drug (baseline)
From half hour prior to till six hour after administration of the drug (baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP)
Time Frame: From half hour prior to till six hour after administration of the drug (baseline)
From half hour prior to till six hour after administration of the drug (baseline)
Mean maximal post-baseline change supine SBP, and (3) the pattern of changes of the SBP and DBP from half hour prior to till six hours after administration of the drug
Time Frame: From half hour prior to till six hour after administration of the drug (baseline)
From half hour prior to till six hour after administration of the drug (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Chi Fai Ng, Dr, Department of Surgery, Division of Urology, The Chinese University of Hong Kong

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

April 1, 2006

Primary Completion

December 7, 2022

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (Estimate)

August 16, 2007

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2006.017-T
  • HARECCTR0500057

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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