Crossover Study From Macitentan or Bosentan Over to Ambrisentan

Stopped early · Phase 4

Conditions studied: Pulmonary Arterial Hypertension

In brief

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).

Key facts

Study ID

NCT02885012

Run by

Medical University of South Carolina

People needed

3

Starts

2016-06-01

Expected to finish

2017-07-07

Last updated by the study team

2019-04-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of a Connective Tissue Disease (CTD)
• Age range: 18-80 years old
• Previous Right Heart Catheterization (RHC) demonstrating PAH
• Forced vital capacity (FVC) greater than 50%
• Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%
• World Health Organization (WHO) functional class II or III
• Able to perform a 6 minute walk test (6MWT)
• Stable dose of antihypertensive medications
• Non-pregnant females
• Have to be currently on stable dose of bosentan for at least 3 months
• Adequate acoustic images to allow for transthoracic echocardiography to be performed

You may not qualify if…

• Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
• Severe systemic hypertension greater than 170/95
• Patients with a prior history of cardiovascular disease
• WHO functional class IV status
• Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
• FVC less than 50% of predicted
• DLCO less than 50% of predicted

Where it is running

• Ochsner Medical Center — New Orleans, Louisiana, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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