Crossover Study From Macitentan or Bosentan Over to Ambrisentan

NCT ID: NCT02885012

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-07-07

Brief 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).

Detailed 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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Switch to Letairis from Bosentan

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

Group Type: EXPERIMENTAL

Ambrisentan

Intervention Type: DRUG

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.

Switch to Letairis from Macitentan

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

Group Type: EXPERIMENTAL

Ambrisentan

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Letairis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ochsner Health System

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terrill Huggins, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Ochsner Medical Center

New Orleans, Louisiana, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00046009

Identifier Type: -

Identifier Source: org_study_id