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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02885012
Recruitment Status : Terminated (Study ending due to lack of enrollment.)
First Posted : August 31, 2016
Results First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Ochsner Health System
Information provided by (Responsible Party):
Medical University of South Carolina

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).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Ambrisentan Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : June 2016
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : July 7, 2017


Arm Intervention/treatment
Experimental: Switch to Letairis from Bosentan
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Drug: 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.
Other Name: Letairis

Experimental: Switch to Letairis from Macitentan
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Drug: 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.
Other Name: Letairis




Primary Outcome Measures :
  1. Change in Stroke Volume [ Time Frame: Baseline and 24 Weeks ]
    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.


Secondary Outcome Measures :
  1. Change in EmPHasis-10 Score [ Time Frame: Baseline and 24 Weeks ]
    Questionnaire-. The questionnaire is designed to determine how pulmonary hypertension affects the patient's life by asking 10 questions which address breathlessness, fatigue, control, and confidence. emPHasis-10 consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.

  2. Disease Status as Measured by Change in Biomarker [ Time Frame: Baseline and 12 Weeks ]
    NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885012


Locations
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United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Ochsner Health System
Investigators
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Principal Investigator: Terrill Huggins, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02885012    
Other Study ID Numbers: 00046009
First Posted: August 31, 2016    Key Record Dates
Results First Posted: April 8, 2019
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Bosentan
Ambrisentan
Macitentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin A Receptor Antagonists
Endothelin B Receptor Antagonists