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

Stopped early · Phase 2

Conditions studied: Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

In brief

The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.

Key facts

Study ID

NCT03714815

Run by

Actelion

People needed

91

Starts

2018-12-07

Expected to finish

2021-10-12

Last updated by the study team

2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated Informed Consent Form (ICF).
• Participant remained in the main study (SERENADE/AC-055G202, NCT03153111) for: a) 52 weeks after randomization if entered this Open-label (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
• A woman of childbearing potential is eligible only if: (1) Negative pre-treatment serum pregnancy test; (2) Agreement to undertake monthly pregnancy tests from the enrollment visit up to at least 30 days after study treatment discontinuation; and (2) 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.

You may not qualify if…

• Premature discontinuation of study treatment in the main study (SERENADE/AC-055G202, NCT03153111) due to an adverse event related to: (1) Edema or fluid retention; (2) Worsening of heart failure; (3) Liver aminotransferase elevation; and (4) Study treatment, based on investigators' discretion
• Liver aminotransferase elevations, at the enrollment visit, fulfilling the following criteria: (1) Alanine amino transferase (ALT) / aspartate aminotransferase (AST) greater than or equal to (>=) 8 * the upper limit of normal (ULN); (2) ALT/AST >= 3 * ULN and associated clinical symptoms of liver injury, for example: nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever); and (3) ALT/AST >= 3 * ULN and associated increase in total bilirubin to >= 2 * ULN
• Treatment with the following forbidden medications within 1 month prior to the enrollment visit: (1) Treatments that may interfere with the assessment of efficacy (that is, endothelin receptor antagonists, prostanoids, phosphodiesterase-5 inhibitors, guanylate cyclase stimulators); (2) Strong cytochrome P-450 3A4 (CYP3A4) inducers such as rifabutin, rifampin, rifampicin, rifapentin, carbamazepine, phenobarbital, phenytoin, or St. John's wort; (3) Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir or a moderate dual CYP3A4/CYP2C9 inhibitor (for example, fluconazole or amiodarone) or co-administration of a combination of moderate CYP3A4 (for example, ciprofloxacin, cyclosporine, diltiazem, erythromycin, verapamil) and moderate CYP2C9 inhibitors (for example, miconazole, piperine), in the 1-month period prior to baseline. This will not necessarily apply to participants who are already well-managed on such an ongoing combination; and (4) any other investigational treatment
• Pregnant, planning to be become pregnant or lactating.
• 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.
• Known hypersensitivity to macitentan or drugs of the same class, or any of the study drug excipients (for example, soy lecithin, lactose)

Where it is running

• South Denver Cardiology Associates PC — Littleton, Colorado, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• University Of Iowa - Hospitals & Clinics — Iowa City, Iowa, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Allegheny — Pittsburgh, Pennsylvania, United States
• North Dallas Research Associates — McKinney, Texas, United States
• Inova Heart and Vascular Institute — Falls Church, Virginia, United States
• MultiCare Health System — Tacoma, Washington, United States
• Aurora Saint Lukes Medical Center — Milwaukee, Wisconsin, United States
• Instituto de Investigaciones Clinicas Mar del Plata — Mar del Plata, Argentina
• Medizinische Universitaet Wien — Vienna, Austria
• Maestri E Kormann Consultoria Médico- Científica Ltda — Blumenau, Brazil
• Instituto do Coracao de Marília — Marília, Brazil
• Diagnostic Consulting Center I Sliven — Sliven, Bulgaria
• Medical Centre Synexus — Sofia, Bulgaria
• Bispebjerg Og Frederiksberg Hospital — Copenhagen, Denmark
• CHU de Grenoble Hopital Albert Michallon — Grenoble, France
• Hopital de Bicetre — Le Kremlin-Bicêtre, France
• CHU Rouen Hopital Charles Nicolle — Rouen, France
• Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie — Dresden, Germany
• Universitaetsklinikum Giessen — Giessen, Germany
• Universitaetsklinikum Schleswig Holstein Campus Kiel — Kiel, Germany
• Semmelweis Egyetem Varosmajor Sziv es Ergyogyaszati Klinika — Budapest, Hungary

Full record on ClinicalTrials.gov

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