Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension
NCT ID: NCT01913847
Last Updated: 2017-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
144 participants
INTERVENTIONAL
2013-09-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sildenafil
Sildenafil 20 mg
Sildenafil
Oral sildenafil 20 mg TID for 12 weeks
Placebo
Placebo
Placebo
Oral placebo TID for 12 weeks
Interventions
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Sildenafil
Oral sildenafil 20 mg TID for 12 weeks
Placebo
Oral placebo TID for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Kyu Hyung Ryu, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hallym University Dongtan Sacred Heart Hospital
Locations
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11 institutions including Hallym University Dongtan Sacred Heart Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Ok
Role: primary
Other Identifiers
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HM-SIL-301
Identifier Type: -
Identifier Source: org_study_id