Status:
UNKNOWN
Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Pulmonary Hypertension
Systolic Dysfunction
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01913847
Start Date
September 1 2013
End Date
December 1 2018
Last Update
November 27 2017
Active Locations (1)
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1
11 institutions including Hallym University Dongtan Sacred Heart Hospital
Seoul, South Korea