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

This study has been completed.
Sponsor:
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00517179
First received: August 15, 2007
Last updated: June 14, 2011
Last verified: June 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00517179     History of Changes
Other Study ID Numbers: CRE-2006.017-T, HARECCTR0500057
Study First Received: August 15, 2007
Last Updated: June 14, 2011
Health Authority: Hong Kong: Ethics Committee

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
Sexual and Gender Disorders
Mental Disorders
Prostatic Diseases
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 18, 2014