A Phase 4 interventional study of Alfuzosin Hydrochloride 10 MG and Tamsulosin Hydrochloride 0.4 MG in Benign Prostatic Hyperplasia, Pupil Anomaly and Choroid Disease, sponsored by Kocatepe University. Completed. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Kocatepe University · Phase 4, Interventional, and Treatment
Among 14 studies testing alfuzosin in Prostatic Hyperplasia — none open to participants now, none under way, none of them phase 3. alfuzosin · Prostatic Hyperplasia.
Among the 14 studies testing alfuzosin in Prostatic Hyperplasia, this one is the 12th largest by enrollment, is the only one that started in 2015, is one of 7 in phase 4, and was the 14th registered.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's enrollment of 63 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →None of the 14 studies testing alfuzosin in Prostatic Hyperplasia is open now.
alfuzosin: first FDA approval 2003 (UROXATRAL). What it is approved for, and how studies give it, is on its page →
Of the 102 Prostatic Hyperplasia studies recruiting now, 70 (69%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 45 Years and older · male · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2015.
Median enrollment 210 across the 14 interventional studies. Of the 14 that completed or were terminated, 0 (0%) have results posted.
11 of 14 have an industry lead sponsor. The 5 most frequent:
Kocatepe University is the lead sponsor of 7 studies on the registry; none are open to participants now.
Kocatepe University has 1 study filed under Prostatic Hyperplasia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies testing alfuzosin in Prostatic Hyperplasia, from their registry updates:
Nothing recorded among them since 2026-09-25.
It was aimed to evaluate and investigate the effects of tamsulosin hydrochloride, has preferential selectivity for the α1A receptor in the prostat versus the α1B receptor in the blood vessels, and alfuzosin hydrochloride on choroidal thickness (CT), pupil diameter sizes evaluated by using enhanced depth imaging spectral-domain optical coherence tomography (EDI-OCT) and scheimpflug/placido photography-based topoghraphy system in this study.
63 men patients with newly diagnosis of benign prostatic hyperplasia were randomly assigned to either alfuzosin hydrochloride or to tamsulosin hydrochloride groups in this prospective, randomized, parallel-group clinical trial. Enhanced depth imaging spectral-domain optical coherence tomography, pupillography were obtained at baseline, 1st and 3rd month, and choroidal thicknesses and pupil diameter sizes were compared between the 2 groups.
The local authorized clinical trials ethics committee approved the study and this study was performed following the principles of the Declaration of Helsinki. Detailed information was given to patients about clinical applications and tests, and signed informed consent forms were also obtained from all patients. 32 right eyes of 32 men with diagnosis of BPH initiated on AH (Xatral®) (10 mg/day) and 31 right eyes of 31 men with diagnosis of BPH initiated on TH (Flomax®) (0.4 mg/day) were included in this self-controlled prospective clinical trial. Urologists in the urology clinic made diagnosis of BPH, and 63 men diagnosis of BPH were directed towards eye clinic. AH or TH treatments were randomly recommended for previously untreated patients with newly diagnosis of BPH by urologists. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study.
Ophthalmological examinations were performed in all cases. Choroidal thicknesses (CTs) were measured under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea, and they were recorded as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses. CTs were measured and recorded by using EDI-OCT imaging (Cirrus HD 4000, Carl Zeis Meditec, CA, USA). Mesopic, scotopic and photopic pupil diameter sizes were measured and recorded by using Scheimpflug/Placido photography-based topography system in the pupillometer mode (Sirius, Italy). CTs, scotopic, mesopic and photopic pupil diameter sizes were measured and recorded at baseline, 1st and 3rd months.
Data obtained from cases were encoded and they were transferred to the computer program. SPSS 20.0 software (SPSS Inc., Chicago, IL, USA) was used for statistical evaluation. Data distribution was tested using Kolmogorov-Smirnov test. Baseline values and 1st, 3rd month values were compared by using the repeated measure of ANOVA in intra-group evaluation and independent samples t-test in inter-group evaluation, and the significance level of p-value was accepted as 0,05 (P ≤ 0, 05). Progressions were evaluated by using repeated measures analyses of variance-ANOVA (with the Bonferroni correction) and the correlation between parameters were evaluated by using bivariate (Pearson's) correlation analysis. Positive values and negative values were considered to be correlated in the same direction and opposite direction, respectively in correlation analysis. Correlation coefficient values r ≥ \|± 0.3\| were accepted as correlation; and the significance level of P value that was below 0,05 was evaluated as the significant correlation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Alfuzosin hydrochloride 10 mg tablet by mouth, every 24 hours for 3 months
Drug: Alfuzosin Hydrochloride 10 MG
Tamsulosin hydrochloride 0.4 mg tablet by mouth, every 24 hours for 3 months
Drug: Tamsulosin Hydrochloride 0.4 MG
Alfuzosin hydrochloride Tablet
Also known as: Xatral
Tamsulosin Hydrochloride Tablet
Also known as: Flomax
Change from baseline choroidal thicknesses at 3 months
Choroidal thicknesses (CTs) measurement under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea at baseline, 1st and 3rd month, and recording as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses.
Time frame: 1 month and 2 months
Change from baseline pupil diameter sizes at 3 months
Mesopic, scotopic and photopic pupil diameter sizes measurement at baseline, 1st and 3rd months
Time frame: 1 month and 2 months
No study locations are listed for this record.
Plan to share: Undecided
Ran from Oct 2015 to primary completion in Feb 2016, 3 months.
Of 28 phase 4 interventional studies under Prostatic Hyperplasia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alfuzosin
Kocatepe University