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
• 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

• Erectile Dysfunction
• Hyperplasia
• Impotence
• Prostatic Hyperplasia

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)