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NCT00517179 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00517179
Other study ID # CRE-2006.017-T
Secondary ID HARECCTR0500057
Status Completed
Phase N/A
First received August 15, 2007
Last updated June 14, 2011
Start date April 2006
Est. completion date May 2007

Study information
Verified date June 2011
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 50 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vardenafil 10mg

Locations
Country Name City State
China Prince of Wales Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 From half hour prior to till six hour after administration of the drug (baseline)
Secondary Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP) From half hour prior to till six hour after administration of the drug (baseline)
Secondary 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 From half hour prior to till six hour after administration of the drug (baseline)
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