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Endothelin Receptor Antagonist

Macitentan for Pulmonary Hypertension (MACiTEPH Trial)

Phase 3
Waitlist Available
Research Sponsored by Actelion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Chronic thromboembolic pulmonary hypertension (CTEPH) (World Health Organization [WHO] Group 4) fulfilling specific criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to eodbt (variable duration per participant, up to 3.5 years)
Awards & highlights

MACiTEPH Trial Summary

This trial will compare the effects of macitentan 75mg to a placebo on exercise capacity in people with CTEPH.

Who is the study for?
This trial is for people with chronic thromboembolic pulmonary hypertension who can walk between 100 to 450 meters in six minutes and are at least WHO functional class II. They must be able to take riociguat unless it's not suitable or available for them. People with severe liver, kidney issues, recent heart attacks or strokes, uncontrolled blood pressure, certain lung diseases, or those on specific medications recently cannot join.Check my eligibility
What is being tested?
The study tests if Macitentan 75 mg improves exercise capacity after 28 weeks compared to a placebo in patients with chronic thromboembolic pulmonary hypertension. Participants will either receive the actual drug or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Macitentan may cause side effects like headache, cold-like symptoms (nasopharyngitis), anemia (low red blood cell counts), bronchitis, urinary tract infections, and dizziness. The severity of these side effects can vary from person to person.

MACiTEPH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a condition called chronic thromboembolic pulmonary hypertension (CTEPH) that meets certain criteria.

MACiTEPH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to eodbt (variable duration per participant, up to 3.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to eodbt (variable duration per participant, up to 3.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to Week 28 in 6- minute Walk Distance [6MWD]
Secondary outcome measures
Change From Baseline to Week 28 in Accelerometer-assessed Proportion of Time Spent in Moderate to Vigorous Physical Activity
Change From Baseline to Week 28 in Pulmonary Arterial Hypertension - Symptoms Based on (PAH-SYMPACT) - Cardiopulmonary Symptom Domain Score
Change from Baseline to Week 28 in PAH-SYMPACT - Cardiovascular Symptom Domain Score
+3 more

Side effects data

From 2019 Phase 4 trial • 89 Patients • NCT02310672
22%
Oedema Peripheral
21%
Headache
14%
Dizziness
11%
Haemoglobin Decreased
11%
Upper Respiratory Tract Infection
11%
Cough
10%
Myalgia
9%
Diarrhoea
9%
Nasal Congestion
8%
Back Pain
8%
Pyrexia
7%
Pain in Extremity
7%
Nasopharyngitis
7%
Nausea
6%
Flushing
3%
Pneumonia
2%
Pulmonary Embolism
2%
Pulmonary Arterial Hypertension
2%
Sepsis
2%
Acute Myocardial Infarction
1%
Cytomegalovirus Infection
1%
Cholangitis Infective
1%
Herpes Zoster
1%
Hypersensitivity
1%
Therapeutic Response Decreased
1%
Escherichia Bacteraemia
1%
Epistaxis
1%
Urinary Tract Infection
1%
Hypoglycaemia
1%
Rheumatoid Arthritis
1%
Pancreatic Carcinoma
1%
Systemic Lupus Erythematosus
1%
Syncope
1%
Acute Kidney Injury
1%
Dysfunctional Uterine Bleeding
1%
Anaemia
1%
Haemolytic Anaemia
1%
Iron Deficiency Anaemia
1%
Angina Pectoris
1%
Atrial Fibrillation
1%
Cardiac Arrest
1%
Coronary Artery Disease
1%
Right Ventricular Failure
1%
Ventricular Hypokinesia
1%
Rectal Haemorrhage
1%
Dysmenorrhoea
1%
Menorrhagia
1%
Pelvic Haemorrhage
1%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Macitentan 10 mg

MACiTEPH Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment2 Interventions
Participants will receive placebo tablets matching the macitentan 10 mg, macitentan 37.5mg and macitentan 75 mg tablets, respectively. Participants who completed the DB period as per protocol either on treatment or in PTOP are eligible for transitioning to the OL extension period and will receive macitentan 75 mg after an 8-week double-dummy uptitration (macitentan 10 mg for 4 weeks, followed by 37.5 mg for another 4 weeks).
Group II: MacitentanExperimental Treatment1 Intervention
Participant will receive macitentan at a dose of 10 milligram (mg) once daily (OD) for 4 weeks, followed by a dose of macitentan 37.5 mg for another 4 weeks and continue with the target dose of macitentan 75 mg. Participants who have reached the target dose of 75 mg, completed the Double-blind (DB) period up to Week 28 (either on treatment or in Post-treatment observation period [PTOP]) at minimum, may be eligible for transitioning into the Open label (OL) extension period once all participants have completed the DB part of the study, or earlier if they experienced a Clinical event committee (CEC) confirmed clinical worsening event.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Macitentan
2020
Completed Phase 4
~1920

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
35,566 Total Patients Enrolled
Actelion Clinical TrialStudy DirectorActelion
13 Previous Clinical Trials
904 Total Patients Enrolled

Media Library

Macitentan (Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04271475 — Phase 3
Thromboembolic Pulmonary Hypertension Research Study Groups: Placebo, Macitentan
Thromboembolic Pulmonary Hypertension Clinical Trial 2023: Macitentan Highlights & Side Effects. Trial Name: NCT04271475 — Phase 3
Macitentan (Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04271475 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this trial?

"The study, which can be found on clinicaltrials.gov, is looking for patients as of now. The trial was first posted on July 7th 2020 and has had its most recent update on November 8th 2022."

Answered by AI

Do people over the age of 50 fit the inclusion criteria for this research project?

"In order to be included in this study, patients must fall between the ages of 18-80. There are currently 62 other studies underway for patients that are under 18 and 715 for those over 65."

Answered by AI

Does Macitentan have any negative side effects for people?

"There is both preclinical and clinical evidence to support the safety of Macitentan, thus it received a score of 3."

Answered by AI

Could you give me a ballpark number of how many individuals are taking part in this trial?

"One hundred and forty-four patients are needed to complete this clinical trial, all of whom must meet the specific inclusion criteria. Patients can elect to participate at various locations, such as Indiana University in Indianapolis, Indiana or the University of Utah Cardiovascular Center in Salt Lake City, Utah."

Answered by AI

What other similar studies have been conducted in the past?

"There are 8 ongoing studies for Macitentan in 88 cities and 46 countries. The first study, sponsored by Actelion, was completed in 2017 with 300 participants. Since then, 18311 other similar trials have been completed."

Answered by AI

In how many different places is this trial being run today?

"With 23 different sites across the United States of America, this clinical trial is currently recruiting patients. While Indianapolis, Salt Lake City and Gainesville are a few of the locations, it is important to select the clinic nearest you to reduce travel demands if you participate."

Answered by AI

Does the medical literature support Macitentan's efficacy?

"Macitentan was first researched in 2017 at Hospital Universitario Vall d'Hebron - PPDS. To date, there have been18311 completed trials and 8 that are still recruiting patients. Many of these studies are based in Indianapolis, Indiana."

Answered by AI

Are there any specific eligibility requirements to take part in this research?

"This trial is looking for 144 participants that have hypertension and are between 18-80 years old. The most crucial requirement for patients is that they must meet one of the following criteria: a) inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease), b) persistent/recurrent CTEPH after balloon pulmonary angioplasty (BPA), and deemed inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease), c) persistent/recurrent CTEPH after rescue pulmonary endarterectomy (PEA), 6-minute"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
2020. "A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04271475.
~27 spots leftby Apr 2025
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