Macitentan for Vascular Diseases

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Ronald Regan UCLA Medical Center, Los Angeles, CA
Vascular Diseases+1 More
Macitentan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether a drug that lowers levels of a molecule called endothelin-1 can help prevent transplant-related disease in the coronary arteries supplying hearts of transplant patients. Macitentan is used to treat Vascular Diseases. Macitentan has previously been approved by the FDA for a different condition and has shown to be effective. No patients in this trial will receive a placebo.

Eligible Conditions

  • Vascular Diseases
  • Transplantation, Homologous

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Vascular Diseases

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Measured during catheterization at 1-year post-transplant

Measured during catheterization at 1-year post-transplant
ET-1 Bioactivity

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Vascular Diseases

Side Effects for

Macitentan 10 mg
22%Oedema Peripheral
21%Headache
14%Dizziness
11%Cough
11%Haemoglobin Decreased
11%Upper Respiratory Tract Infection
10%Myalgia
9%Diarrhoea
9%Nasal Congestion
8%Back Pain
8%Pyrexia
7%Nausea
7%Nasopharyngitis
7%Pain in Extremity
6%Flushing
3%Pneumonia
2%Pulmonary Embolism
2%Pulmonary Arterial Hypertension
2%Acute Myocardial Infarction
2%Sepsis
1%Herpes Zoster
1%Acute Kidney Injury
1%Dysfunctional Uterine Bleeding
1%Dysmenorrhoea
1%Anaemia
1%Rectal Haemorrhage
1%Cytomegalovirus Infection
1%Haemolytic Anaemia
1%Iron Deficiency Anaemia
1%Pancreatic Carcinoma
1%Angina Pectoris
1%Rheumatoid Arthritis
1%Epistaxis
1%Escherichia Bacteraemia
1%Therapeutic Response Decreased
1%Coronary Artery Disease
1%Right Ventricular Failure
1%Ventricular Hypokinesia
1%Systemic Lupus Erythematosus
1%Hypoglycaemia
1%Pelvic Haemorrhage
1%Atrial Fibrillation
1%Urinary Tract Infection
1%Cardiac Arrest
1%Cholangitis Infective
1%Dyspnoea
1%Syncope
1%Hypersensitivity
1%Menorrhagia
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT02310672) in the Macitentan 10 mg ARM group. Side effects include: Oedema Peripheral with 22%, Headache with 21%, Dizziness with 14%, Cough with 11%, Haemoglobin Decreased with 11%.

Trial Design

1 Treatment Group

Intervention Arm
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Macitentan · No Placebo Group · Phase 4

Intervention Arm
Drug
Experimental Group · 1 Intervention: Macitentan · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Macitentan
2020
Completed Phase 4
~1850

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured during catheterization at 1-year post-transplant
Closest Location: Ronald Regan UCLA Medical Center · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2016First Recorded Clinical Trial
2 TrialsResearching Vascular Diseases
6 CompletedClinical Trials

Who is running the clinical trial?

American Heart AssociationOTHER
280 Previous Clinical Trials
5,824,156 Total Patients Enrolled
2 Trials studying Vascular Diseases
280 Patients Enrolled for Vascular Diseases
Janssen, LPIndustry Sponsor
144 Previous Clinical Trials
200,296 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,382 Previous Clinical Trials
6,521,172 Total Patients Enrolled
2 Trials studying Vascular Diseases
1,105 Patients Enrolled for Vascular Diseases
Rushi Parikh, MDPrincipal InvestigatorAssistant Clinical Professor; University of California, Los Angeles

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References