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

Information source: Hospital Authority, Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Hyperplasia; Impotence

Intervention: Vardenafil 10mg (Drug)

Phase: N/A

Status: Completed

Sponsored by: Hospital Authority, Hong Kong

Official(s) and/or principal investigator(s):
Chi Fai Ng, Dr, Principal Investigator, Affiliation: Department of Surgery, Division of Urology, The Chinese University of Hong Kong

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.

Clinical Details

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

Primary outcome: 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:

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

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

Prince of Wales Hospital, Hong Kong, China
Additional Information

Starting date: April 2006
Last updated: June 14, 2011

Page last updated: August 23, 2015

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