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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
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Description
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Brief Summary:
Study ROR-PH-302, ADVANCE CAPACITY, is designed to evaluate the effects of ralinepag therapy on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from cardiopulmonary exercise testing (CPET) after 28 weeks of treatment

Condition or disease Intervention/treatment Phase
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

Detailed Description:
ROR-PH-302 is a 28-week multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 2:1 to receive ralinepag or placebo, in addition to their PAH-specific background therapy, as applicable. The primary endpoint is change from Baseline in peak VO2 (assessed by CPET) at Week 28. All subjects who complete the study on study drug through Week 28 will have the option to receive ralinepag in an open-label extension (OLE) study.
Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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)
 Drug: Ralinepag
Oral ralinepag
Other Name: APD811
Placebo Comparator: Placebo
Matching placebo tablets (oral)
 Drug: Placebo
Matching oral tablets


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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).

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years of age
  2. Primary diagnosis of PAH
  3. Has had a diagnostic RHC performed within 1 year of Screening
  4. Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) 2 to 3 symptoms
  5. 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
  6. Has a 6-minute walk distance (6MWD) of ≥150 meters at Screening
  7. Has a VE/VCO2 slope ≥38 during the Screening CPET, as assessed by the CPET core lab
  8. 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:

  1. Has left ventricular disease
  2. Current unstable angina
  3. Symptomatic coronary disease and/or myocardial infarction within past 6 months
  4. Current symptomatic aortic or mitral valve disease
  5. Has evidence of more than mild lung disease on pulmonary function tests (PFTs) performed within 1 year prior to, or during, Screening
  6. Has evidence of thromboembolic disease
  7. Current diagnosis of uncontrolled sleep apnea in the opinion of the Investigator
  8. Requires use of supplemental oxygen during CPET
  9. Respiratory exchange ratio (RER) <1.0 at Screening CPET as determined by the CPET core laboratory
  10. Acute non-cardiac disorder that may affect exercise performance or be aggravated by exercise (eg, infection, renal failure, thyrotoxicosis)
  11. Male subjects with a QTcF >450 msec and female subjects with QTcF >470 msec on electrocardiogram (ECG)
  12. 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: United Therapeutics Global Medical Information 919-485-8350 clinicaltrials@unither.com

Locations
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Sponsors and Collaborators
United Therapeutics
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by United Therapeutics:
Prostacyclin
Connective Tissue Disease-Associated
Cardiopulmonary Exercise Capacity (CPET)
IP Receptor Agonist
Additional relevant MeSH terms:
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Lung Diseases
Hypertension, Pulmonary
Respiratory Tract Diseases
Familial Primary Pulmonary Hypertension
 Hypertension
Cardiovascular Diseases
Vascular Diseases
Connective Tissue Diseases