Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT00696761
Eligibility Criteria:
Inclusion Criteria:
* Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
* Patients satisfying all of the following:
* Moderate to severe LUTS :
* international prostate symptom score (IPSS)≥ 8
* An enlarged prostate (≥25 mL)
* Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)
Exclusion Criteria:
* Post voided residual urine ≥ 200 mL
* Patients performing catheterization
* Urinary tract infection patients
* Patients taking 5 alpha reductase inhibitor
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Hypertension patients treated with other alpha1-blockers
* Patients newly taking anticholinergic medication within 1 month
* Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
* Renal insufficiency (s-Cr ≥ 2mg/dL)
* Unstable angina pectoris
* Uninvestigated hematuria
* Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
* Interstitial cystitis patients
* Severe concomitant condition threatening life.
* Patient who is unable to make voiding diary
* Bladder or prostate cancer patients
* Patients receiving prostate or bladder surgery
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT00696761
Study Brief:
Protocol Section:
NCT00696761