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

NCT00517179 | Completed

• 2 other identifiers: CRE-2006.017-THARECCTR0500057
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia; Impotence

Keywords

Benign Prostatic Hyperplasia (BPH); Erectile Dysfunction (ED)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Interventions

Vardenafil 10mg DRUG

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Chi Fai Ng, Dr

  Department of Surgery, Division of Urology, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: April 1, 2006
• Study Completion: May 1, 2007
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

CN (1)