Crossover Study From Macitentan or Bosentan Over to Ambrisentan

NCT02885012 | Terminated Phase 4 Results

• 1 other identifier: 00046009
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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).

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Stroke Volume

  Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat.

  Baseline and 24 Weeks

Secondary Outcomes (2)

• Change in EmPHasis-10 Score

  Baseline and 24 Weeks

• Disease Status as Measured by Change in Biomarker

  Baseline and 12 Weeks

Study Arms (2)

Switch to Letairis from Bosentan

EXPERIMENTAL

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

Drug: Ambrisentan

Switch to Letairis from Macitentan

EXPERIMENTAL

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

Drug: Ambrisentan

Interventions

Ambrisentan 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.

Also known as: Letairis

Switch to Letairis from Bosentan; Switch to Letairis from Macitentan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Ochsner Health System: collaborator

Study Sites (2)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: John Terrill Huggins
• Organization: Medical University of South Carolina

hugginjt@musc.edu

(843) 792-2296

Study Officials

• Terrill Huggins, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: August 31, 2016
• Study Start: June 1, 2016
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: April 8, 2019
• Results First Posted: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)