An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensio
- Conditions
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Pulmonary arterial hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code 10077731Term: Pulmonary hypertension WHO functional class ISystem Organ Class: 100000004855
- Registration Number
- EUCTR2018-001189-40-PT
- Lead Sponsor
- nited Therapeutics Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
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 Form
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 (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.
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
F.1.3.1 Number of subjects for this age range 200
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 breastfeeding
5. 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.
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, 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 Outcome Measures
Name Time Method