Prostatic HyperplasiaNCT00517179
Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS
A study testing Vardenafil 10mg in people with Prostatic Hyperplasia and Impotence, run by Hospital Authority, Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Impotence
- What is being tested?
- Vardenafil 10mg
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Apr 2006to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Vardenafil 10mg
- Keywords
- Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction (ED)
- Medical subject headings
- Prostatic Hyperplasia, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vardenafil 10mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: From half hour prior to till six hour after administration of the drug (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startApr 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Chi Fai Ng, Dr, Principal investigator, Department of Surgery, Division of Urology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517179
- Sponsor's protocol ID
- CRE-2006.017-T
- Other IDs
- HARECCTR0500057
- Status last verified
- Jun 2011
- First submitted
- 15 Aug 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00517179
- Acronym / sponsor ID
- CRE-2006.017-T
- Conditions
- Prostatic Hyperplasia, Impotence
- Keywords
- Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction (ED)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Apr 2006
- Study completion
- May 2007 (actual)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 50 to 80 years old
- Clinically diagnosed to have lower urinary tract symptoms secondary to BPH:
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vardenafil 10mg | Drug | – |
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
Time frame: From half hour prior to till six hour after administration of the drug (baseline)
2 secondary outcomes
Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP)
Time frame: 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
Time frame: From half hour prior to till six hour after administration of the drug (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai Ng, Dr principal investigator
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vardenafil 10mg in people with Prostatic Hyperplasia and Impotence, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From half hour prior to till six hour after administration of the drug (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.