A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Pati… (NCT03626688) | Clinical Trial Compass
CompletedPhase 3
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
United States687 participantsStarted 2018-08-30
Plain-language summary
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age.
✓. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
✓. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
✓. Primary diagnosis of symptomatic PAH.
✓. Has had a right heart catheterization (RHC) performed at or within 3 years prior to Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH.
✓. Has WHO/ NYHA functional class II to IV symptoms.
✓. If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator.
✓. Has a 6MWD of ≥150 meters.
Exclusion criteria
✕. For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count \<200/mm3 within 90 days of Baseline.
✕. Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol.
✕. Has evidence of more than mild lung disease on pulmonary function tests performed within 180 days prior to, or during Screening.
What they're measuring
1
Time from randomization to the first adjudicated protocol-defined clinical worsening event
Timeframe: The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years
✕. Has evidence of thromboembolic disease as determined by a V/Q lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH.
✕. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator.
✕. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) \>450 msec and female subjects with a QTcF \>470 msec on ECG recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval greater than 110 msec, will be excluded if the QTcF is \>500 msec for both males and females.
✕. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy).
✕. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).