Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Phase III Study to Evaluate Efficacy and Safety of HGP1207 in Patients With Pulmonary Hypertension Associated With Systolic Heart Failure

Conditions
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Pulmonary Hypertension, Systolic Dysfunction

Intervention / Treatment
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* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of chronic heart failure (NYHA Class II and III) LVEF ≤ 40% Elevated systolic PAP: ≥ 40 mmHg Patients must be treated with an ACE inhibitor, ARB, beta-blocker, aldosterone antagonist at a stable dose for at least 4 weeks prior to visit 1 Exclusion Criteria: Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease, interstitial lung disease, chronic thromboembolism or unclear/multifactorial mechanisms Patients who have received Nitrates/NO donor or Cytochrome P450 3A4 inhibitors within 30 days prior to visit 1 Patients who have received calcium channel blocker, endothelin receptor antagonist, prostacyclin analogues, phosphodiesterase 5 inhibitors within 90 days prior to visit 1 History of hypersensitivity or allergy to sildenafil or any excipients of its formulation Patients with hypertension (sitSBP >170 mmHg or sitDBP>100 mmHg) or hypotension (sitSBP<90 mmHg or sitDBP<50 mmHg) Patients with other medical condition (i.e.,alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation Pregnant females or those of child bearing potential who have not had a negative pregnancy test

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil<br>Sildenafil 20 mg | Drug: Sildenafil<br>* Oral sildenafil 20 mg TID for 12 weeks<br>* Other names: PAHTENSION chewable tablet;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Oral placebo TID for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 6-min-walk test distance |  | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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] |  | 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 |