Status:
COMPLETED
Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension
Lead Sponsor:
United Therapeutics
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (P...
Detailed Description
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with WHO Group 1 PAH who completed Study APD811-003. Subjects who completed Stu...
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document.
- Was willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and was deemed an appropriate candidate for participation in a long-term extension study.
- Female subjects were nonpregnant, nonlactating, surgically sterile or postmenopausal, or agreed to use an accepted method of birth control for at least 3 months prior to the first dose, during, and for at least 30 days after the last dose of study drug.
- Male subjects were either surgically sterile or agreed to use a condom with spermicide when sexually active with a female partner who was not using an acceptable method of birth control during the study and for 30 days after the last dose of study drug.
- Male and female subjects agreed not to participate in a conception process during the study and for 30 days after the last dose of study drug.
- Fulfilled all eligibility criteria for Study APD811-003 and completed the study as planned.
- Subjects who were assigned to placebo in Study APD811-003 and experienced clinical worsening in that study could enroll in Study APD811-007 after completing all end of study procedures per protocol, including RHC, for Study APD811-003 and had their data locked.
Exclusion
- Subjects who enrolled in Study APD811-003 and were withdrawn from study drug treatment due to any adverse event (AE), serious adverse event (SAE), or subjects who did not complete Study APD811003, with the exception made for placebo-treated subjects who experienced a clinical worsening event.
- Female •subjects who wished to become pregnant.
- Systolic blood pressure \<90 mmHg at Baseline.
- Other severe acute or chronic medical or laboratory abnormalities that could have increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator, would have made the subject inappropriate for entry into this study.
Key Trial Info
Start Date :
July 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02279745
Start Date
July 8 2015
End Date
March 29 2021
Last Update
December 22 2021
Active Locations (46)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
3
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
4
University of California Davis Medical Center
Sacramento, California, United States, 95817