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

Sponsor

Hospital Authority, Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT00517179

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia Impotence	Drug: Vardenafil 10mg	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2006

Actual Study Completion Date :

May 1, 2007

Outcome Measures

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 [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) [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 [From half hour prior to till six hour after administration of the drug (baseline)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

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