Crossover Study From Macitentan or Bosentan Over to Ambrisentan (Letairis)

Medical University of South Carolina (MUSC)

Status and phase: Terminated; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Ambrisentan

Study type: Interventional

Funder types: Other

Identifiers

NCT02885012

00046009

Details and patient eligibility

About

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).

Full description

The study will consist of a group of subjects who have been on bosentan for at least three months and a group that has been on macitentan for at least three months. Both groups will be switched to Letairis 5mg daily after the bosentan or macitentan therapy for three months and then increased to a dose of Letairis 10mg daily at week 4 if well tolerated.

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

3 participants in 2 patient groups

Switch to Letairis from Bosentan

Experimental group

Description:

Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)

Treatment:

Drug: Ambrisentan

Switch to Letairis from Macitentan

Experimental group

Description:

Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)

Treatment:

Drug: Ambrisentan