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

August 15, 2007
June 14, 2011
April 2006
Not Provided
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) ]
Same as current
Complete list of historical versions of study NCT00517179 on ClinicalTrials.gov Archive Site
  • 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) ]
Same as current
Not Provided
Not Provided
 
Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Prostatic Hyperplasia
  • Impotence
Drug: Vardenafil 10mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2007
Not Provided

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
Male
50 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00517179
CRE-2006.017-T, HARECCTR0500057
Not Provided
Not Provided
Hospital Authority, Hong Kong
Not Provided
Principal Investigator: Chi Fai Ng, Dr Department of Surgery, Division of Urology, The Chinese University of Hong Kong
Hospital Authority, Hong Kong
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP