A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH

Part of paid clinical trials in Tucson, Arizona.

Sponsor
United Therapeutics
Study ID
NCT04084678
Phase
PHASE3
Status
Terminated

Conditions

  • Cardiovascular Diseases
  • Connective Tissue Disease
  • Familial Primary Pulmonary Hypertension
  • Hypertension
  • Hypertension, Pulmonary
  • Lung Diseases
  • PAH
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Respiratory Tract Disease
  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ralinepag — DRUG
    Oral ralinepag
  • Placebo — DRUG
    Matching oral tablets

Study Details

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

Key Dates

Start date
Jan 20, 2021
Status verified
Oct 2023
Primary completion
Apr 12, 2023
Completion
Apr 12, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ralinepag
    Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)
  • Placebo Comparator: Placebo
    Matching placebo tablets (oral)

Primary Outcome Measure

Change from Baseline in peak VO2 assessed by CPET [ Time Frame: Baseline to Week 28 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Banner University Medical Center (University of Arizona)TucsonArizona85724-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
National Jewish HealthDenverColorado80206-
Tampa General Hospital/University of South Florida Center for Advanced Lung Disease and Lung TransplantTampaFlorida33606-
Medical College of Wisconsin/Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Tucson, AZ

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Banner University Medical Center (University of Arizona)· Tucson, AZUniversity of Colorado Anschutz Medical Campus· Aurora, CONational Jewish Health· Denver, COTampa General Hospital/University of South Florida Center for Advanced Lung Disease and Lung Transplant· Tampa, FLMedical College of Wisconsin/Froedtert Hospital· Milwaukee, WI

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