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The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction
A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo |
|
| Treatment 2 | Experimental | HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo |
|
| Active Comparator | Active Comparator | HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1303 capsule 5/0.2mg | Drug |
| ||
| HCP1303 capsule 5/0.4mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Total IPSS (International Prostate Symptom Score) | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Total IPSS | baseline and 4weeks, 8sweeks |
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Inclusion Criteria:
At Visit 1
At Visit 2 1. Total IPSS ≥ 13
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Se Woong Kim, M.D.,Ph.D. | Catholic University of Seoul St.Mary's Hospital | Principal Investigator |
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|
| HGP1201 | Drug |
|
| HCP1303 capsule 5/0.2mg placebo | Drug |
|
| HCP1303 capsule 5/0.4mg placebo | Drug |
|
| HGP1201 placebo | Drug |
|
| 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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