Crossover Study From Macitentan or Bosentan Over to Ambrisentan

NCT02885012 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-04-08

Study results available
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Summary

The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).

Conditions

Interventions

DRUG

Ambrisentan

At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.

Sponsors & Collaborators

  • Ochsner Health System

    collaborator OTHER
  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Terrill Huggins, MD · Medical University of South Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-07-07
Completion
2017-07-07

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02885012 on ClinicalTrials.gov