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The purpose of this study is to investigate the safety and clinical efficacy of HGP1207 (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil | Experimental | Sildenafil 20 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | Oral sildenafil 20 mg TID for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 6-min-walk test distance | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 6-min-walk test distance | at 6 weeks | |
| Change from baseline in systolic pulmonary arterial pressure (PAP) | at 6 weeks and 12 weeks | |
| Change from baseline in [NT pro-BNP] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bae | Contact | monobhy@hanmi.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kyu Hyung Ryu, M.D. Ph.D. | Hallym University Dongtan Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 11 institutions including Hallym University Dongtan Sacred Heart Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug | Oral placebo TID for 12 weeks |
|
| at 6 weeks and 12 weeks |
| Improvement in NYHA functional class | at 6 weeks and 12 weeks |
| Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS) | at 6 weeks and 12 weeks |
| Delaying time to first occurrence of either cardiovascular events | 12 weeks |
| D002318 |
| Cardiovascular Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |