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| Name | Class |
|---|---|
| Astellas Pharma Taiwan, Inc. | INDUSTRY |
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This is an open-label, single-arm, prospective interventional study to assess the tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
After obtaining informed consent, subjects who meet the inclusion criteria and not violating the exclusion criteria will be enrolled to receive Harnalidge® OCAS® 0.4 mg for treatment. The interventional period for the study is three months after the first date of enrollment or until the patients are discontinued the treatment of Harnalidge® OCAS®. All subjects will be instructed to contact the site if a patient's partner becomes pregnant during or within 90 days from the discontinuation of dosing, the investigator should report the information to the sponsor as if it is an SAE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harnalidge® OCAS® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin OCAS | Drug | oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in total scores of International Prostate Symptom Score (IPSS) | baseline, 4-week, 8-week, 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in IPSS subscore | IPSS subscores include storage subscores, voiding subscores and nocturia | baseline, 4-week, 8-week, 12 week |
| Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linkou District | Taiwan |
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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| baseline, 4-week, 8-week, 12 week |
| Changes from baseline in Uroflowmetry parameters | Uroflowmetry parameters include Qmax, Qave, and voided volume | baseline, 4-week, 8-week, 12 week |
| Changes from baseline in Visual Analogue Scale (VAS) | VAS is a vertical mark on a 10-cm line that ran from 'Not at all' to 'Yes, completely'. Patient marks on the line the point that they feel represents their perception of treatment satisfaction; 'Not at all' = 0 to 'Yes, completely' =10 | baseline, 4-week, 8-week, 12 week |
| Safety assessed by the adverse events, physical examination, vital signs and post void residual volume | Up to 12 week |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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