A long term study to find out if macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular disease

Phase 1

• Conditions: Heart failure with preserved ejection fraction and pulmonary vascular disease; MedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001603-37-BG
• Lead Sponsor: ACTELION Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

1. Signed and dated ICF.
2. Subject remained in the main study (SERENADE / AC-055G202, EudraCT number 2016-003653-15) for:
a. 52 weeks after randomization if entered this OL extension study
prior to protocol Version 4.
b. At least 24 weeks after randomization if entering this OL extension
study under protocol Version 4.
3. A woman of childbearing potential is eligible only if all of the following apply:
• Negative pre-treatment serum pregnancy test.
• Agreement to undertake monthly pregnancy tests from the enrollment visit up to at least 30 days after study treatment discontinuation.
• Agreement to use reliable contraception from at least 30 days prior to the enrollment visit up to at least 30 days after study treatment discontinuation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 129

Exclusion Criteria

1. Premature discontinuation of study treatment in the main study (SERENADE / AC-055G202, EudraCT number 2016-003653-15) due to an adverse event related to:
a. Edema or fluid retention
b. Worsening of heart failure
c. Liver aminotransferase elevation
d. Study treatment, based on investigators` discretion
2. Liver aminotransferase elevations outside of normal range at the enrollment visit fulfilling the following criteria:
a. associated clinical symptoms of liver injury, e.g., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever)
b. associated increase in total bilirubin outside of normal range
3. Treatment with the following forbidden medications within 1 month prior to the enrollment visit:
a. Treatments that may interfere with the assessment of efficacy
(i.e., endothelin receptor antagonists, prostanoids, phosphodiesterase-5 inhibitors, guanylate cyclase stimulators)
b. Strong cytochrome P-450 3A4 (CYP3A4) inducers such as rifabutin, rifampin, rifampicin, rifapentin, carbamazepine, phenobarbital, phenytoin, or St. John’s wort
c. Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and
saquinavir or a moderate dual CYP3A4/CYP2C9 inhibitor (eg,
fluconazoleor amiodarone) or co-administration of a combination of
moderate CYP3A4 (eg, ciprofloxacin, cyclosporine, diltiazem,
erythromycin, verapamil) and moderate CYP2C9 inhibitors (eg,
miconazole, piperine), in the 1-month period prior to baseline. This will
not necessarily apply to subjects who are already well-managed on such
an ongoing combination.
d. any other investigational treatment
4. Pregnant, planning to be become pregnant or lactating.
5. Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
6. Known hypersensitivity to macitentan or drugs of the same class, or any of the study drug excipients (e.g. soy lecithin, lactose)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified