Prostatic DiseasesPhase 4ALEX-XLNCT00575913
Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study
A Phase 4 study testing Alfuzosin in people with Prostatic Diseases, run by Sanofi at 1 site in Thailand.
Trial summary
To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Diseases
- What is being tested?
- Alfuzosin
- Type of treatment
- Pill or oral medicine
- How many people
- 118 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2003to Mar 2005
- Phase
- Phase 4
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH.
Who cannot join
- Patients requiring BPH surgery immediately or within the 12 following months:
- Acute renal obstruction
- Chronic renal obstruction
- Chronic renal failure from BPH
- Bladder stone
- Recurrent urinary tract infection
Show all 21Show fewer
- Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)
- Hematuria from BPH
- Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)
- Patients previously not improved by an alpha1-blocker treatment
- Known hypersensitivity to alfuzosin
- History of postural hypotension or syncope
- Combination with other alpha1-blockers
- Hepatic enzyme (SGOT or/and SGPT ) > 1.5 Upper Normal Limit
- Unstable angina pectoris
- Severe concomitant condition threatening life.
- Patients who had failed treatment with finasteride (Proscar)
- Patients with neuropathic bladder.
- Patients with history of previous surgery for BPH
- Patients with high risk for prostate cancer based on the clinical judgement of the investigator
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study
To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).
- Conditions
- Prostatic Diseases
- Being tested
- Alfuzosin
- Medical subject headings
- Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
Also called (Xatral XL)
Alfuzosin 10 mg One tablet per day after evening meal
What is being measured
The primary outcome is the main question the study is designed to answer.
improvements in urinary symptoms and quality of life index
Measured: During all the study conduct
Secondary outcomes (3)
Improvement in sexual function
Measured: During all the study conduct
Improvement in maximum flow rate (determined by uroflowmetry)
Measured: During all the study conduct
Collection of spontaneously reported adverse events
Measured: At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startSep 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic DiseasesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paibulsirijit Sompob, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575913
- Sponsor's protocol ID
- L_8935
- Acronym
- ALEX-XL
- Status last verified
- Apr 2008
- First submitted
- 17 Dec 2007
- Last updated
- 10 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study
- ClinicalTrials.gov ID
- NCT00575913
- Acronym / sponsor ID
- ALEX-XL / L_8935
- Conditions
- Prostatic Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Mar 2005 (actual)
- First posted
- 18 Dec 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.
To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH.
Key exclusion criteria (21 listed)
- Patients requiring BPH surgery immediately or within the 12 following months:
- Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)
- Patients previously not improved by an alpha1-blocker treatment
- Known hypersensitivity to alfuzosin
- History of postural hypotension or syncope
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 |
|---|---|---|
| AlfuzosinAlso: (Xatral XL)Alfuzosin 10 mg One tablet per day after evening meal | Drug | – |
Primary outcome
improvements in urinary symptoms and quality of life index
Time frame: During all the study conduct
3 secondary outcomes
Improvement in sexual function
Time frame: During all the study conduct
Improvement in maximum flow rate (determined by uroflowmetry)
Time frame: During all the study conduct
Collection of spontaneously reported adverse events
Time frame: At each visit
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 10 Apr 2008.
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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.
Paibulsirijit Sompob study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfuzosin in people with Prostatic Diseases, run by Sanofi at 1 site in Thailand.
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 1 inclusion and 21 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 10 Apr 2008. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
improvements in urinary symptoms and quality of life index (time frame: During all the study conduct). 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 10 Apr 2008.