Find trials
Consejos para buscar

GS-4997 in Adults With Pulmonary Arterial Hypertension

Overview

Información sobre este estudio

This study will compare the efficacy, safety, and tolerability of three doses of GS-4997 to placebo in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term GS-4997 treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with GS-4997 in the long-term treatment period.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Diagnosis of idiopathic pulmonary arterial hypertension (IPAH), heritable pulmonary arterial hypertension (HPAH), drug- and toxin-induced PAH, or PAH associated with connective tissue disease, HIV infection, or congenital heart defects (repaired greater than 1 year prior to Screening)

  • Meet all of the following hemodynamic criteria by means of a screening right heart catheterization (RHC) completed prior to randomization:

    • Mean pulmonary artery pressure (mPAP) of ≥ 25 mm Hg
    • Pulmonary vascular resistance (PVR) ≥ 400 dyne•sec/cm^5
    • Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mm Hg if PVR ≥ 400 and < 500 dynes•sec/cm^5, or PCWP/LVEDP ≤ 15 mm Hg if PVR ≥ 500 dynes•sec/cm^5
  • Be able to walk a distance of at least 100 m
  • Have World Health Organization (WHO) Functional Class II or III symptoms

  • Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation:

    • Forced expiratory volume in one second (FEV1) ≥ 55% of predicted normal
    • FEV1:forced vital capacity (FVC) ratio ≥ 0.60
  • Receiving treatment with one or more drugs approved for PAH for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks

Exclusion Criteria:

  • Diagnosis of PAH associated with significant venous or capillary involvement (PCWP > 15 mm Hg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects
  • Pulmonary hypertension (PH) belonging to groups 2 to 5 of the 2013 NICE classification
  • Left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant ischemic, valvular or constrictive heart disease
  • Uncontrolled hypertension (≥ 180/110 mm Hg) at Screening
  • End stage renal disease (receiving peritoneal dialysis, hemodialysis, or status after renal transplantation)
  • Severe liver disease (Child-Pugh Class C, with or without cirrhosis)

Individuals may be rescreened one additional time with prior notification to and approval by the sponsor.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Robert Frantz, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

.
CLS-20143001

Mayo Clinic Footer