A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH (CAPACITY)
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ClinicalTrials.gov Identifier: NCT04084678 |
Recruitment Status :
Recruiting
First Posted : September 10, 2019
Last Update Posted : April 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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PAH Pulmonary Hypertension Hypertension Connective Tissue Disease Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Disease Pulmonary Arterial Hypertension | Drug: Ralinepag Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 193 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy |
Actual Study Start Date : | October 29, 2020 |
Estimated Primary Completion Date : | September 1, 2023 |
Estimated Study Completion Date : | September 1, 2023 |

Arm | Intervention/treatment |
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Experimental: Ralinepag
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose (maximum dose of 1400 mcg)
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Drug: Ralinepag
Oral ralinepag
Other Name: APD811 |
Placebo Comparator: Placebo
Matching placebo tablets (oral)
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Drug: Placebo
Matching oral tablets |
- Change from Baseline in peak VO2 assessed by CPET [ Time Frame: Baseline to Week 28 ]Peak VO2 by CPET was measured at Baseline (prior to starting study drug) and Week 28
- Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: Baseline to Week 28 ]NT-proBNP was measured at Baseline (prior to starting study drug) and Weeks 4, 8, 12, 16, 20, 24 and 28
- Change from Baseline in Minute Ventilation (VE)/Carbon Dioxide output (VCO2) slope [ Time Frame: Baseline to Week 28 ]VE/VCO2 slope (from CPET) was calculated at Baseline (prior to starting study drug) and Week 28
- Change from Baseline in Health-related quality of life (HRQoL) measured by the Short Form Health Survey (SF-36) Scores [ Time Frame: Baseline to Week 28 ]SF-36 was assessed at Baseline (prior to starting study drug) and Weeks 16 and 28. The SF-36 consisted of 36 questions in 8 health categories (Vitality, Physical Functioning, Bodily Pain, General Health Perception, Role Physical, Role Emotional, Social Functioning, and Mental Health). Responses to the questions were graded on a numerical scale, with 1 as the best score and higher numbers as worse scores. The raw scores from the subscales were converted and summed by the Investigator to a total score between 0 and 100 to measure functional health and well-being from the patient's point of view. The final score range was 0 (representing the lowest possible score; worst health state) to 100 (representing the highest possible score; best health state).
- Time to First All-cause Non-elective Hospitalization [ Time Frame: Baseline to Week 28 ]The time to first all-cause nonelective hospitalization during the study period will be assessed.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years of age
- Primary diagnosis of PAH
- Has had a diagnostic RHC performed within 1 year of Screening
- Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) 2 to 3 symptoms
- Must have initiated first PAH-specific oral therapy with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a sGC stimulator within 9 months prior to Screening
- Has a 6-minute walk distance (6MWD) of ≥150 meters at Screening
- Has a VE/VCO2 slope ≥38 during the Screening CPET, as assessed by the CPET core lab
- Has a peak VO2 of ≥10 to <18 mL·kg-1·min-1 during the Screening CPET, as assessed by the CPET core lab
Exclusion Criteria:
- Has left ventricular disease
- Current unstable angina
- Symptomatic coronary disease and/or myocardial infarction within past 6 months
- Current symptomatic aortic or mitral valve disease
- Has evidence of more than mild lung disease on pulmonary function tests (PFTs) performed within 1 year prior to, or during, Screening
- Has evidence of thromboembolic disease
- Current diagnosis of uncontrolled sleep apnea in the opinion of the Investigator
- Requires use of supplemental oxygen during CPET
- Respiratory exchange ratio (RER) <1.0 at Screening CPET as determined by the CPET core laboratory
- Acute non-cardiac disorder that may affect exercise performance or be aggravated by exercise (eg, infection, renal failure, thyrotoxicosis)
- Male subjects with a QTcF >450 msec and female subjects with QTcF >470 msec on electrocardiogram (ECG)
- Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine, or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084678
Contact: United Therapeutics Global Medical Information | 919-485-8350 | clinicaltrials@unither.com |

Responsible Party: | United Therapeutics |
ClinicalTrials.gov Identifier: | NCT04084678 |
Other Study ID Numbers: |
ROR-PH-302 |
First Posted: | September 10, 2019 Key Record Dates |
Last Update Posted: | April 8, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Prostacyclin Connective Tissue Disease-Associated Cardiopulmonary Exercise Capacity (CPET) IP Receptor Agonist |
Lung Diseases Hypertension, Pulmonary Respiratory Tract Diseases Familial Primary Pulmonary Hypertension |
Hypertension Cardiovascular Diseases Vascular Diseases Connective Tissue Diseases |