Heart Failure Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

91

Study ID:

NCT03714815

Recruitment Status:

Terminated

Sponsor:

Actelion

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There are 42 Locations for this study

See Locations Near You

South Denver Cardiology Associates PC
Littleton Colorado, 80120, United States
Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
University Of Iowa - Hospitals & Clinics
Iowa City Iowa, 52242, United States
University of Maryland
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Allegheny
Pittsburgh Pennsylvania, 15212, United States
North Dallas Research Associates
McKinney Texas, 75069, United States
Inova Heart and Vascular Institute
Falls Church Virginia, 22042, United States
MultiCare Health System
Tacoma Washington, 98405, United States
Aurora Saint Lukes Medical Center
Milwaukee Wisconsin, 53215, United States
Instituto de Investigaciones Clinicas Mar del Plata
Mar Del Plata, Buenos Aires , B7600, Argentina
Medizinische Universität Wien
Vienna , 1090, Austria
Maestri E Kormann Consultoria Médico- Científica Ltda
Blumenau , 89020, Brazil
Instituto do Coracao de Marília
Marilia , 17515, Brazil
Diagnostic - Consulting Center I-Sliven
Sliven , 8800, Bulgaria
Medical Centre Synexus
Sofia , 1784, Bulgaria
Bispebjerg Og Frederiksberg Hospital
Copenhagen , 2400, Denmark
CHU de Grenoble - Hopital Albert Michallon
Grenoble Cedex 9 , , France
Hopital de Bicetre
Le Kremlin Bicetre , 94270, France
CHU Rouen - Hopital Charles Nicolle
Rouen Cedex , 76031, France
Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
Dresden , 01307, Germany
Universitaetsklinikum Giessen
Giessen , 35392, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel , 24105, Germany
Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika
Budapest , 1122, Hungary
Barzilai Medical Center
Ashkelon , , Israel
Hillel Yaffe Medical Center
Hadera , 38101, Israel
Bnai Zion Medical Center
Haifa , 33394, Israel
Galilee Medical Center
Nahariya , 22100, Israel
Rabin Medical Center, Beilinson Campus
Petah Tikva , 49414, Israel
Kaplan Medical Center
Rehovot , 76100, Israel
Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn
Krakow , 31-20, Poland
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
Lublin , 20-71, Poland
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Wroclaw , 50-51, Poland
Cardiomed
Craiova , 20050, Romania
SAL MED Pitesti
Pitesti , 11043, Romania
Cmi Dr Podoleanu Cristian
Targu-Mures , 54050, Romania
Ekaterinburg City Clinical Hospital #14
Ekaterinburg , 62003, Russian Federation
Federal State Budget Scientific Institution
Kemerovo , 65000, Russian Federation
Moscow City Clinical Hospital No.51
Moscow , 12130, Russian Federation
Federal State Budgetary Institution
St Petersburg , 19734, Russian Federation
Sahlgrenska Universitetsjukhuset
Goteborg , 413 4, Sweden
Royal Free Hospital
London , NW3 2, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

91

Study ID:

NCT03714815

Recruitment Status:

Terminated

Sponsor:


Actelion

How clear is this clinincal trial information?

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