Last updated 47 days ago

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

1000 patients around the world
Available in Argentina, Chile, Brazil, Mexico
Study ROR-PH-301 is a multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo, in addition to their standard of care or PAH-specific background therapy, as applicable. The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical worsening event. All primary endpoint events will be adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study who have completed the Week 28 Visit (after the target number of confirmed events is achieved) will have the option to enroll in an open-label extension (OLE) study. Subjects who do not choose to participate in the OLE study will discontinue study drug and should remain in the study for long-term follow-up of survival status and will receive standard of care PAH treatment, at the discretion of the treating physician.
United Therapeutics
23Research sites
1000Patients around the world

This study is for people with

Pulmonary hypertension
Pulmonary arterial hypertension

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Sites

Instituto de Investigaciones Clínicas Mar del Plata
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Av. Colón 3456, Mar del Plata, Buenos Aires
Sociedad de Beneficencia Hospital Italiano - Córdoba
Recruiting
Roma 550, Bº General Paz, Córdoba
Hospital Británico de Buenos Aires - CABA
Hospital Británico de Buenos Aires - CABA
Recruiting
Perdriel 74, CABA, Buenos Aires
Hospital Privado de Córdoba
Recruiting
Naciones Unidas 346, Córdoba
Fundación Favaloro para la Docencia e Investigación Médica - CABA, Buenos Aires
Recruiting
Av. Belgrano 1782, CABA, Buenos Aires
Sanatorio Parque - Rosario
Recruiting
Boulevard Oroño 860, Rosario, Santa Fe
CIPSIC SRL - Cardiología Palermo - CABA
Recruiting
Charcas 4189 pisos 1 y 3 (C1425BNG)
Hospital Dr. José María Cullen
Recruiting
Av. Freyre 2150, Santa Fe
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH
Instituto de Cardiología Juana Francisca Cabral - Corrientes
Recruiting
Simón Bolivar 1334, Corrientes
LinkedinInstagramFacebook
Terms and ConditionsPrivacy Policy