Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01913847
• Other study ID #: HM-SIL-301
• Status: Recruiting
• Phase: Phase 3
• First received: July 30, 2013
• Last updated: November 24, 2017
• Start date: September 2013
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Bae
• Email: monobhy[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Systolic Dysfunction

Intervention

Drug:
• Sildenafil
Oral sildenafil 20 mg TID for 12 weeks
• Placebo
Oral placebo TID for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	11 institutions including Hallym University Dongtan Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in 6-min-walk test distance		at 12 weeks
Secondary	Change from baseline in 6-min-walk test distance		at 6 weeks
Secondary	Change from baseline in systolic pulmonary arterial pressure (PAP)		at 6 weeks and 12 weeks
Secondary	Change from baseline in [NT pro-BNP]		at 6 weeks and 12 weeks
Secondary	Improvement in NYHA functional class		at 6 weeks and 12 weeks
Secondary	Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS)		at 6 weeks and 12 weeks
Secondary	Delaying time to first occurrence of either cardiovascular events		12 weeks