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Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin + Solifenacin | Experimental | Tamsulosin and Solifenacin |
|
| Tamsulosin + Solifenacin Placebo | Active Comparator | Tamsulosin and Solifenacin placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Tamsulosin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change of TUFS((Total Urgency and Frequency Score)/24h | From baseline at week 12 | |
| The change of total IPSS(International prostate symptom score) | From baseline at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of urgency/24h | From baseline at week 4, 8 and 12 | |
| The change of voiding frequency/24h | From baseline at week 4, 8 and 12 | |
| The change of nocturnal frequency/24h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| moah Son | Contact | sonmoah@ildong.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung medical center | Recruiting | Seoul | South Korea |
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| Solifenacin |
| Drug |
Solifenacin |
|
| Solifenacin placebo | Drug | Solifenacin placebo |
|
| From baseline at week 4, 8 and 12 |
| The change of urge urinary incontinence frequency/24h | From baseline at week 4, 8 and 12 |
| The change of IPSS(International prostate symptom score)-sub score | From baseline at week 4, 8 and 12 |
| The change of PPBC(Patient perception of bladder condition) | From baseline at week 4 and 12 |
| The change of IPSS(International prostate symptom score) QoL(Quality of Life) | From baseline at week 4, 8 and 12 |
| PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change) | From baseline at week 12 |
| The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4 | From baseline at week 12 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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