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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04273945




Registration number
NCT04273945
Ethics application status
Date submitted
31/01/2020
Date registered
18/02/2020
Date last updated
25/11/2020

Titles & IDs
Public title
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
Scientific title
A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg
Secondary ID [1] 0 0
2019-002533-11
Secondary ID [2] 0 0
CR108740
Universal Trial Number (UTN)
Trial acronym
UNISUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Macitentan 10 mg
Treatment: Drugs - Macitentan 37.5 mg
Treatment: Drugs - Macitentan 75 mg
Treatment: Drugs - Placebo

Active Comparator: Macitentan 10 milligrams (mg) + Placebo - Participants will receive macitentan 10 mg once daily (qd) orally for 4 weeks in open-label Run-in phase prior to randomization (only for participants who are Endothelin Receptor Antagonist (ERA) treatment-naive. Other participants will bypass the Run-in period and go directly to randomization). Double-blind Treatment Period: participants will receive macitentan 10 mg qd and matching placebo of macitentan 37.5 for 4 weeks (Uptitration) and 75 mg thereafter orally up to End of Double-Blind Treatment period (EDBT). Treatment Extension Period: After EDBT, participants will receive macitentan 37.5 mg qd and macitentan 75 mg matching placebo orally for 4 weeks (Uptitration), followed by open-label macitentan 75 mg qd orally for 2 years.

Experimental: Macitentan 75 mg + Placebo - Participants will receive macitentan 10 mg qd orally for 4 weeks in open-label Run-in phase prior to randomization (only for ERA treatment-naive. Other participants will bypass the Run-in period and go directly to randomization). Double-blind Treatment Period: participants will receive macitentan 37.5 for 4 weeks (Uptitration) and 75 mg qd along with matching placebo for macitentan 10 mg orally up to EDBT. Treatment Extension Period: After EDBT, participants will receive macitentan 75 mg qd and macitentan 37.5 mg matching placebo orally for 4 weeks (Uptitration), followed by open-label macitentan 75 mg qd orally for 2 years.


Treatment: Drugs: Macitentan 10 mg
Participants will receive macitentan 10 mg film-coated tablets orally.

Treatment: Drugs: Macitentan 37.5 mg
Participants will receive macitentan 37.5 mg film-coated tablets orally.

Treatment: Drugs: Macitentan 75 mg
Participants will receive macitentan 75 mg film-coated tablets orally.

Treatment: Drugs: Placebo
Participants will receive matching placebo film-coated tablets orally.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events - Time to first CEC-adjudicated M/M event on-treatment (that is up to 7 days after the last dose of double-blind study treatment) is defined as time from baseline to the first of the following events: All-cause death, including deaths caused by an on-treatment adverse event (AE) that occur within 4 weeks of study DB treatment discontinuation; non-planned Pulmonary Arterial Hypertension (PAH)-related hospitalization (including for worsening of PAH, atrial septostomy, lung transplantation with or without heart transplantation, or initiation of parenteral prostacyclins); and PAH-related disease progression, defined as deterioration by at least 15 percent (%) in exercise capacity, as measured by the 6-Minute Walk Distance (6MWD), from baseline, confirmed by two 6MWD tests performed on separate days within 2 weeks of each other and Initiation of additional PAH therapy or Worsening of World Health Organization Functional Class (WHO FC).
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWD - The 6MWT is a non-encouraged test performed to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Timepoint [1] 0 0
Baseline up to Week 24
Secondary outcome [2] 0 0
Double-blind Treatment Period: Time to First occurrence of either CEC-adjudicated Death or Hospitalization due to PAH - Time to first occurrence of either CEC-adjudicated death or hospitalization due to PAH will be reported.
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiopulmonary Symptom Domain Score - The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH symptoms and impact questionnaire (PAH-SYMPACT) is completed daily for a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items.
Timepoint [3] 0 0
Baseline up to Week 24
Secondary outcome [4] 0 0
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain Score - The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT is completed daily for a 7 day period. The recall period of symptom items is the last 24 hours. An average cardiovascular symptoms domain score is determined based on the daily scores of the 5 items.
Timepoint [4] 0 0
Baseline up to Week 24
Secondary outcome [5] 0 0
Double-blind Treatment Period: Time to Death Occurring Between Baseline and End of Double-blind Treatment (EDBT) - Time to death occurring between baseline and EDBT will be reported.
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Double-blind Treatment Period: Number of Deaths - Number of deaths will be reported.
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Double-blind Treatment Period: Number of Participants with Intervention-emergent AEs - Number of participants with intervention-emergent AEs will be reported.
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
Double-blind Treatment Period: Number of Participants with AEs Leading to Premature Discontinuation of Study Drug - Number of participants with AEs Leading to premature discontinuation of study drug will be reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
Double-blind Treatment Period: Number of Participants With Intervention-emergent AEs of Special Interest - Number of participants with intervention-emergent AEs of Special Interest (that is, liver events, hemoglobin decrease/anemia, hypotension, edema/fluid retention) will be reported.
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
Double-blind Treatment Period: Number of Participants With Serious Adverse Events (SAEs) - Number of participants with SAEs will be reported.
Timepoint [10] 0 0
Up to 4 years
Secondary outcome [11] 0 0
Double-blind Treatment Period: Number of Participants with Intervention-emergent Electrocardiogram (ECG) Abnormalities - Number of participants with intervention-emergent ECG abnormalities will be reported.
Timepoint [11] 0 0
Up to 4 years
Secondary outcome [12] 0 0
Double-blind Treatment Period: Number of Participants with Intervention-emergent Laboratory Abnormalities - Number of participants with intervention-emergent laboratory abnormalities will be reported.
Timepoint [12] 0 0
Up to 4 years
Secondary outcome [13] 0 0
Double-blind Treatment Period: Change from Baseline in Blood Pressure - Change from baseline in blood pressure will be reported.
Timepoint [13] 0 0
Baseline up to 4 years
Secondary outcome [14] 0 0
Double-blind Treatment Period: Change from Baseline in Heart Rate - Change from baseline in heart rate will be reported.
Timepoint [14] 0 0
Baseline up to 4 years
Secondary outcome [15] 0 0
Treatment Extension Period: Time to Death Occurring Between Baseline and End of Study (EOS) - Time to death occurring between baseline and EOS will be reported.
Timepoint [15] 0 0
Up to 6 years
Secondary outcome [16] 0 0
Treatment Extension Period: Number of Deaths - Number of deaths will be reported.
Timepoint [16] 0 0
Up to 6 years
Secondary outcome [17] 0 0
Treatment Extension Period: Number of Participants With Intervention-emergent AEs - Number of participants with intervention-emergent AEs will be reported.
Timepoint [17] 0 0
Up to 6 years
Secondary outcome [18] 0 0
Treatment Extension Period: Number of Participants With AEs Leading to Premature Discontinuation of study Drug - Number of participants with AEs leading to premature discontinuation of study drug will be reported.
Timepoint [18] 0 0
Up to 6 years
Secondary outcome [19] 0 0
Treatment Extension Period: Number of Participants with Intervention-emergent AEs of Special Interest - Number of participants with intervention-emergent AEs of Special Interest (liver events, hemoglobin decrease/anemia, hypotension, edema/fluid retention) will be reported.
Timepoint [19] 0 0
Up to 6 years
Secondary outcome [20] 0 0
Treatment Extension Period: Number of Participants With SAEs - Number of participants with SAEs will be reported.
Timepoint [20] 0 0
Up to 6 years
Secondary outcome [21] 0 0
Treatment Extension Period: Number of Participants With Intervention-emergent Laboratory Abnormalities - Number of participants With intervention-emergent laboratory abnormalities will be reported.
Timepoint [21] 0 0
Up to 6 years
Secondary outcome [22] 0 0
Treatment Extension Period: Change from Baseline in Blood Pressure - Change from baseline in blood pressure will be reported.
Timepoint [22] 0 0
Baseline up to 6 years
Secondary outcome [23] 0 0
Treatment Extension Period: Change from Baseline in Heart Rate - Change from baseline in heart rate will be reported.
Timepoint [23] 0 0
Baseline up to 6 years

Eligibility
Key inclusion criteria
- Target population: greater than or equal to (>=) 18 (or the legal age of consent in
the jurisdiction in which the study is taking place) years of age

- Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health
Organization Functional Class (WHO FC) II, III, or IV

- Target population: PAH subtype falling in one of the below classifications:
Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease,
HIV infection, Portal hypertension, and Congenital heart disease with simple
systemic-to-pulmonary shunt (atrial septal defect, ventricular septal defect, patent
ductus arteriosus) with persistent PH documented by an Right heart catheterization
(RHC) >= 1 year after surgical repair

- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to
screening: Mean pulmonary artery pressure (mPAP) > 20 millimeters of mercury (mmHg),
and; Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure
(LVEDP) less than or equal to (<=) 15 mmHg, and PVR >= 3 Wood Units (that is, >= 240
dyn*sec/cm^5)

- Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters
and maximum distance of 440 meters at screening
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known presence of three or more of the following risk factors for heart failure with
preserved ejection fraction at screening, based on records that confirm documented
medical history: Body mass index (BMI) > 30 kilograms per meter square (kg/m^2),
Diabetes mellitus of any type, Essential hypertension (even if well controlled);
Coronary artery disease, that is, any of the following: history of stable angina, or
known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial
infarction, or history of or planned coronary artery bypass grafting and/or coronary
artery stenting

- Known presence of moderate or severe obstructive lung disease (forced expiratory
volume in 1 second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of
predicted after bronchodilator administration) as documented by a spirometry test
performed within 1 year prior to screening

- Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based
on records that confirm documented medical history

- Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >
1.5*upper limit of normal (ULN) at screening

- Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
St Vincent's hospital - Darlinghurst
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment outside Australia
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Ukraine
State/province [140] 0 0
Ivano-Frankivsk
Country [141] 0 0
Ukraine
State/province [141] 0 0
Kharkiv
Country [142] 0 0
Ukraine
State/province [142] 0 0
Kyiv
Country [143] 0 0
Ukraine
State/province [143] 0 0
Lviv
Country [144] 0 0
Ukraine
State/province [144] 0 0
Ternopil
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Cambridge
Country [146] 0 0
United Kingdom
State/province [146] 0 0
London
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Newcastle Upon Tyne
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Sheffield
Country [149] 0 0
Vietnam
State/province [149] 0 0
Hanoi
Country [150] 0 0
Vietnam
State/province [150] 0 0
Ho Chi Minh City
Country [151] 0 0
Vietnam
State/province [151] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in
prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or
mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH)
compared to macitentan 10 mg.
Trial website
https://clinicaltrials.gov/show/NCT04273945
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Actelion Clinical Trials
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04273945