Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Phase 3

• Conditions: Pulmonary Hypertension; Systolic Dysfunction
• Interventions: Drug: Sildenafil; Drug: Placebo

• Registration Number: NCT01913847
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-01
• Study Start: 2013-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-24
• Last Update Posted: 2017-11-27
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	Sildenafil 20 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in 6-min-walk test distance	at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in NYHA functional class	at 6 weeks and 12 weeks
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
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

Trial Locations

Locations (1)

11 institutions including Hallym University Dongtan Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of