Source URL
https://www.inova.org/clinical-trials/phase-3-open-label-multicenter-study-evaluate-long-term-safety-and-tolerability
Description
General Information Age Group Adults Status Closed Protocol Number LTI-301 Background Information The purpose of this study to evaluate the long-term safety and tolerability of inhaled LIQ861 (treprostinil) using a dry powder inhaler. National Clinical Trial (NCT) identifier on clinicaltrials.gov: NCT03399604 Offered At Inova Heart and Vascular Institute Advanced Lung Disease and Transplant Clinic 3300 Gallows Road, Falls Church, VA 22042 Principal Investigator Oksana Shlobin, MD Eligibility Information Male or female patients =/> 18 years of age Diagnosed with PAH belonging to Nice Clinical Classification Grp 1 NYHA Functional Class II-IV at Screening Can complete a baseline 6MWD =/> 150m FEV1 =/> 60% and FEV1/FVC ratio =/> 60% during the 6 month period before enrollment Ineligibility Information Diagnosed with PH in the Nice Classification Groups 2-5, or PAH Group 1 subgroups 1.4.3 (associated with portal hypertension) or 1.4.5 (associated with schistosomiasis) Patient is currently taking oral prostacyclin analogues or agonists, including treprostinil and selexipag Uncontrolled systemic hypertension (=/>160/100 mmHg) Has had an atrial septostomy Has had a pulmonary infarction within 2 weeks of screening Pregnancy Has had a stroke or transient ischemic attack within 6 months of screening Severe hepatic or renal impairment Contact Information Contact Name Danielle DaCosta, RN Contact Phone 703-776-5539 Contact Email Send Email
Clinical Trials Category
Lung
Clinical Trials Sub categories
Pulmonary Hypertension
Crawled Content Type
Clinical Trials
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Age Group
Adults
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