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

This study has been completed.

Sponsored by: Hospital Authority, Hong Kong
Information provided by: Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT00517179
  Purpose

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.


Condition Intervention
Prostatic Hyperplasia
Impotence
Drug: Vardenafil 10mg

MedlinePlus related topics:   Erectile Dysfunction   

ChemIDplus related topics:   Vardenafil    Doxazosin    Doxazosin mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:   Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS for the Treatment of Benign Prostatic Hyperplasia

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]

Estimated Enrollment:   40
Study Start Date:   April 2006
Study Completion Date:   May 2007

  Eligibility
Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517179

Locations
China
Prince of Wales Hospital    
      Hong Kong, China

Sponsors and Collaborators
Hospital Authority, Hong Kong

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


HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CRE-2006.017-T, HARECCTR0500057
First Received:   August 15, 2007
Last Updated:   June 16, 2008
ClinicalTrials.gov Identifier:   NCT00517179
Health Authority:   Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Benign Prostatic Hyperplasia (BPH)  
Erectile Dysfunction (ED)  

Study placed in the following topic categories:
Sexual Dysfunctions, Psychological
Hyperplasia
Vardenafil
Sexual Dysfunction, Physiological
Prostatic Diseases
Prostatic Hyperplasia
Mental Disorders
Genital Diseases, Male
Erectile Dysfunction
Doxazosin

Additional relevant MeSH terms:
Phosphodiesterase Inhibitors
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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