Crossover Study From Macitentan or Bosentan Over to Ambrisentan

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02885012
• Date of registration: 03/05/2016
• Prospective Registration: Yes
• Primary sponsor: Medical University of South Carolina
• Public title: Crossover Study From Macitentan or Bosentan Over to Ambrisentan Letairis
• Scientific title: A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)
• Date of first enrolment: June 2016
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02885012
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Terrill Huggins, MD
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Ambrisentan

Primary Outcome(s)

Change in Stroke Volume [Time Frame: Baseline and 24 Weeks]

Secondary Outcome(s)

Disease Status as Measured by Change in Biomarker [Time Frame: Baseline and 12 Weeks]

Change in EmPHasis-10 Score [Time Frame: Baseline and 24 Weeks]

Secondary ID(s)

00046009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ochsner Health System

Results

• Results available: Yes
• Date Posted: 08/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02885012