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The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin 0.4mg | Experimental |
| |
| tamsulosin 0.2mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin 0.4mg | Drug | Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T) | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment. | 4 weeks and 12 weeks of treatment | |
| Changes of parameters in voiding diary after 4 and 12 weeks treatment. | 4 weeks and 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24725169 | Derived | Kim JJ, Han DH, Sung HH, Choo SH, Lee SW. Efficacy and tolerability of tamsulosin 0.4 mg in Asian patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to tamsulosin 0.2 mg: a randomized placebo controlled trial. Int J Urol. 2014 Jul;21(7):677-82. doi: 10.1111/iju.12412. Epub 2014 Apr 13. |
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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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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Tamsulosin 0.2mg | Drug | tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal. |
|
| D052801 |
| Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |