Status:
WITHDRAWN
Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH)
Detailed Description
This is a study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH). Participants comple...
Eligibility Criteria
Inclusion
- Diagnosis of PAH as classified by idiopathic, heritable, drug and toxin- induced, congenital heart disease or associated with connective tissue disease (i.e., WHO Group 1)
- Clinical diagnosis of PAH confirmed by RHC at any time prior to Visit 1
- WHO functional status of Class II-IV at Visit 1
- Two 6MWD test measurements between 100 and 450 meters with a relative difference of ≤15%. The baseline 6MWD test must be performed at Visit 2 before randomization.
- Have a qualifying RHC performed between Visit 1 and Visit 2
- On stable dose(s) of guideline-directed medical therapy for PAH (endothelin receptor antagonists, phosphodiesterase type-5 (PDE-5) inhibitors, soluble guanylate cyclase stimulators and prostacyclin pathway analogs) for at least 90 days prior to the qualifying RHC
Exclusion
- PAH associated with portal hypertension, human immunodeficiency virus (HIV), schistosomiasis or sickle cell disease as well as participants with pulmonary parenchymal disease or thromboembolic disease
- Known significant left heart disease including: left ventricular dysfunction (i.e., left ventricular ejection fraction \<35%); hemodynamically compromising, symptomatic, or severe aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation
- Pulmonary hypertension belonging to WHO groups 2 to 5
- Moderate to severe obstructive lung disease defined as forced expiratory volume in 1 second (FEV1) \<55% of predicted value
- Moderate to severe restrictive lung disease defined as total lung capacity (TLC) \<60% of predicted value
- Acute decompensated heart failure or hospital admission for worsening PAH symptoms within 30 days prior to the qualifying RHC
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03789643
Start Date
March 1 2019
End Date
June 1 2021
Last Update
May 3 2019
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