A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-Label Extension (ADVANCE-Extension) - ADVANCE-extension

nited Therapeutics Corporation0 sites1,000 target enrollmentDecember 19, 2018

ConditionsPulmonary arterial hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code 10077731Term: Pulmonary hypertension WHO functional class ISystem Organ Class: 100000004855 Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pulmonary arterial hypertension (PAH)
Sponsor: nited Therapeutics Corporation
Enrollment: 1000
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 19, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

nited Therapeutics Corporation

Eligibility Criteria

Inclusion Criteria

•Each subject must meet ALL of the following inclusion criteria to be eligible for enrollment into the study:
•1\. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study\-related procedures.
•2\. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•3\. Completed the protocol\-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.
•4\. 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 (i.e., 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 800
•F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

•Eligible subjects must not meet ANY of the following exclusion criteria to be eligible for enrollment into the study:
•1\. 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.
•2\. Subjects who withdrew consent during participation in another ralinepag study.
•3\. Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit).
•4\. Women who are pregnant, lactating or breast\-feeding
•5\. Subjects who have undergone lung or heart/lung transplant or are receiving longterm parenteral (intravenous \[i.v.] infusion or subcutaneous infusion) or inhaled therapy with a prostacyclin or oral therapy with another IP receptor agonist (selexipag) during the time since participation in their original ralinepag study.
•6\. 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\.
•7\. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 ralinepag study.
•8\. Known hypersensitivity to ralinepag or any of the excipients.
•9\. Any reason that, in the opinion of the investigator or medical monitor, precludes the subject from participating in the study, e.g., non\-compliance 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.