EUCTR2018-001603-37-DK进行中（未招募）1 期
A long-term, multicenter, single-arm, open-label extension of the SERENADE study, to assess the safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease - SERENADE O
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •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, fluconazole or 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).
研究者
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