Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

July 1, 2014

Primary Completion Date

November 27, 2017

Study Completion Date

December 31, 2017

Conditions
Systemic SclerosisPulmonary Hypertension
Interventions
DRUG

Ambrisentan

"Titration:~As common practice of the clinic, the patient will adapt the dose from 5 mg to 10 mg after 1 to 4 weeks according to tolerability and after consultation (by phone or personally) with one of the investigators.~Additionally, at each study visit the investigator needs to decide, based on the patient's well-being, patients´ assessment, safety parameters, and tolerance of ambrisentan, if the study medication should be modified. The respective decision (increase, maintain or decrease dose) must be documented.~Maximum dose allowed: not to exceed 10 mg/day.~Administration:~Ambrisentan and placebo will be administered orally with or without food intake."

DRUG

Placebo

Placebo tablet (one to two tablets corresponding to one to two verum tablets)

Trial Locations (1)

69126

Thoraxclinic at the University of Heidelberg, Heidelberg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Heidelberg University

OTHER

NCT02290613 - Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) | Biotech Hunter | Biotech Hunter