Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
United Therapeutics
Study ID
NCT02279745
Phase
PHASE2
Status
Completed

Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 8, 2015
Status verified
Nov 2021
Primary completion
Mar 29, 2021
Completion
Mar 29, 2021

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Ralinepag
    Ralinepag immediate-release (IR) capsules of 10, 20, 30, 40, and 100 mcg or extended-release (XR) tablets of 50, 250, and 400 mcg for oral administration.

Primary Outcome Measure

Change From Baseline in Pulmonary Vascular Resistance [ Time Frame: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2. ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
Cedars-Sinai Medical CenterBeverly HillsCalifornia90211-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
University of California Davis Medical CenterSacramentoCalifornia95817-
Harbor-UCLA Medical CenterTorranceCalifornia90502-
University of Colorado Cardiac and Vascular Center, Anschutz Inpatient PavilionAuroraColorado80045-
Cleveland Clinic FloridaWestonFlorida33331-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Chest Medicine AssociatesPortlandMaine04106-
University of Maryland Medical CenterBaltimoreMaryland21201-
Boston University Medical Center General Clinical Research Unit (GCRU)BostonMassachusetts02118-
University of Michigan Health SystemAnn ArborMichigan48109-
UC HealthCincinnatiOhio45219-
University Hospitals Case Medical CenterClevelandOhio44106-
The Ohio State University Wexner Medical Center - Martha Morehouse Medical PavilionColumbusOhio43221-
UPMC, PresbyterianPittsburghPennsylvania15229-
UT Southwestern Medical CenterDallasTexas75390-
Memorial Hermann Hospital - Texas Medical CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCedars-Sinai Medical Center· Beverly Hills, CADavid Geffen School of Medicine at UCLA· Los Angeles, CAUniversity of California Davis Medical Center· Sacramento, CAHarbor-UCLA Medical Center· Torrance, CAUniversity of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavilion· Aurora, CO

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