Back to resultsEffect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS
Primary Purpose
Prostatic Hyperplasia, Impotence
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vardenafil 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction (ED)
Eligibility Criteria
Inclusion Criteria:
- Age between 50 to 80 years old
Clinically diagnosed to have lower urinary tract symptoms secondary to BPH:
- Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) >=8
- Detectable prostatic enlargement determined by Digital Rectum Examination (DRE)
- 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
Sites / Locations
- Prince of Wales Hospital
Outcomes
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
Secondary Outcome Measures
Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP)
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
Full Information
NCT ID
NCT00517179
First Posted
August 15, 2007
Last Updated
June 14, 2011
Sponsor
Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00517179
Brief Title
Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Impotence
Keywords
Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction (ED)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vardenafil 10mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Age between 50 to 80 years old
Clinically diagnosed to have lower urinary tract symptoms secondary to BPH:
Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) >=8
Detectable prostatic enlargement determined by Digital Rectum Examination (DRE)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Fai Ng, Dr
Organizational Affiliation
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS
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