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

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ClinicalTrials.gov Identifier: NCT00517179
Recruitment Status : Completed
First Posted : August 16, 2007
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
Hospital Authority, Hong Kong

Brief Summary:
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 or disease Intervention/treatment Phase
Prostatic Hyperplasia Impotence Drug: Vardenafil 10mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : April 2006
Actual Study Completion Date : May 2007

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Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. 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) ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00517179     History of Changes
Other Study ID Numbers: CRE-2006.017-T
HARECCTR0500057
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

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

Additional relevant MeSH terms:
Hyperplasia
Erectile Dysfunction
Prostatic Hyperplasia
Pathologic Processes
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Prostatic Diseases
Vardenafil Dihydrochloride
Doxazosin
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