Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Systolic Dysfunction; Pulmonary Hypertension

Treatments: Drug: Placebo; Drug: Sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01913847

HM-SIL-301

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups, including a placebo group

Sildenafil

Experimental group

Description:

Sildenafil 20 mg

Treatment:

Drug: Sildenafil

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo