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Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with symptomatic BPS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALNA® | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire | Baseline, after 1 month | |
| Change of Quality of Life (QoL) Index by means on patient questionnaire | Baseline, after 1 month | |
| Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale | after 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in maximum urinary flow rate (Qmax) | Baseline, after 1 month | |
| Change from Baseline in residual urinary volume | Baseline, after 1 month | |
| Change from Baseline in blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic BPS, who switched for ALNA® after preceding Terazosin therapy recruited at urologists
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Baseline, after 1 month |
| Change from Baseline in Pulse rate (bpm) | Baseline, after 1 month |
| Change in complications due to low blood pressure | Patient is asked for complications (weakness, dizziness, nausea) | Baseline, after 1 month |
| Global assessment of efficacy by investigator on 4-point scale | after 1 month |
| Global assessment of tolerability by investigator on 4-point scale | after 1 month |
| Global assessment with BPS- treatment by investigator on a 4-point scale | Switch from Terazosin therapy to ALNA® | Baseline, after 1 month |
| D052801 |
| Male Urogenital Diseases |