An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensio
- Conditions
- Pulmonary arterial hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code: 10077731Term: Pulmonary hypertension WHO functional class I Class: 10038738Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-509305-68-00
- Lead Sponsor
- nited Therapeutics Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 633
Evidence of a personally signed and dated Informed Consent Form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures., Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures., Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study., Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through the 30-Day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (ie, actively attempt to become pregnant or to impregnate; sperm donation; in vitro fertilization) during the study and for 30 days after the last dose of ralinepag.
Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol-defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study., Subjects who withdrew consent during participation in another ralinepag study., Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit)., Women who are pregnant, lactating, or breastfeeding, Subjects who have undergone lung or heart/lung transplant or are receiving longterm parenteral (intravenous [IV] or subcutaneous [SC] infusion) or inhaled therapy with a prostacyclin or oral therapy with another IP receptor agonist during the time since participation in their original ralinepag study., Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec and female subjects with QTcF >470 msec on electrocardiogram (ECG) recorded within 12 weeks prior to Day 1., Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 ralinepag study., Known hypersensitivity to ralinepag or any of the excipients., Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the subject from participating in the study, eg, noncompliance concerns, any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: The secondary objectives of the study are to evaluate the long-term effects of ralinepag on the following parameters: • N-terminal pro-brain natriuretic peptide (NT- proBNP) • 6-Minute Walk Distance (6MWD) • WHO/New York Heart Association (NYHA) Functional Class (FC) • Health-related quality of life (HRQoL) measures • Time to all-cause hospitalization • Time to all-cause mortality;Primary end point(s): Efficacy assessments will include an evaluation of: •NT-proBNP •6MWD •WHO/NYHA FC •The proportion of subjects who achieve all 3 of the following (at specified time points): oNT-proBNP level <300 pg/mL o6MWD >440 meters oWHO/NYHA FC II status or better •HRQoL measures (where validated) •Time to all-cause hospitalization during the study period •Time to all-cause mortality during the study period;Main Objective: To evaluate the long-term safety and tolerability of ralinepag (APD811) in subjects who have participated in a preceding Phase 2 or Phase 3 study of ralinepag.
- Secondary Outcome Measures
Name Time Method