Phase 2
N=45
Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02279745 ↗Enrolled (actual)
45
Serious AEs
46.7%
Results posted
Dec 2021
Primary outcome: Primary: Change From Baseline in Pulmonary Vascular Resistance — -52.2 dynes.sec/cm5
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ralinepag (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- United Therapeutics
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pulmonary Vascular Resistance |
-52.2 | — |
| PRIMARY Change From Baseline in Cardiac Output |
-0.0 | — |
| PRIMARY Change From Baseline in Cardiac Index |
0.0 | — |
| PRIMARY Change From Baseline in Mean Pulmonary Arterial Pressure |
-2.0 | — |
| SECONDARY Time From Randomization to the First Protocol-defined Clinical Worsening Event |
56.50 | — |
| SECONDARY Change From Baseline in 6MWD |
20.9; 17.6; 22.8; 28.5; 16.2; 16.0 | — |
| SECONDARY Change From Baseline in WHO/NYHA FC |
1; 43; 0; 2; 37; 3 | — |
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 (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical worsening.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02279745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.