CTRI/2023/02/049676招募中3 期
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 75mg - UNISUS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 At least 18 years of age
- •2 Symptomatic PAH in WHO FC II, III, or IV
- •3 PAH subtype falling in one of the below classifications:
- •4 Idiopathic, heritable, drug- or toxin-induced, or
- •related to connective tissue disease, HIV infection,
- •portal hypertension, or congenital heart disease
- •5 Have a PAH diagnosis confirmed by hemodynamic
- •evaluation at rest at any time prior to screening:
- •- Mean pulmonary artery pressure (mPAP) >
- •20 mm Hg, AND
- •- Pulmonary artery wedge pressure (PAWP) or
- •left ventricular end diastolic pressure (LVEDP)
- •= 15 mm Hg, AND
- •- Pulmonary vascular resistance (PVR) = 3 Wood Units (i.e., = 240 dyn•sec•cm-5)
- •Additional criteria will be assessed at the screening visit.
排除标准
- •1 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 kg/m2
- •- Diabetes mellitus of any type
- •- Essential hypertension (even if well controlled)
- •- Coronary artery disease, i.e., any of the following:
- •– History of stable angina, known more than
- •50% stenosis in a coronary artery, history of
- •myocardial infarction, or history of or planned
- •coronary artery bypass grafting and/or coronary
- •artery stenting
- •2 Presence of moderate or severe obstructive or restrictive
- •lung disease in patients with a known or suspected
- •history of significant lung disease
- •Additional criteria will be assessed at the screening visit.
- •3 Treatment with a strong CYP3A4 inducer (eg, rifabutin, rifampin, rifampicin,
- •rifapentin, carbamazepine, phenobarbital, phenytoin, St. John’s Wort) within 1 month
- •prior to randomization or start of run-in, if applicable
- •4 Treatment with a strong CYP3A4 inhibitor (eg, ketoconazole, itraconazole,
- •voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) or a
- •moderate dual CYP3A4/CYP2C9 inhibitor (eg, fluconazole, amiodarone) or coadministration
- •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 randomization, or start of run-in, if applicable.
- •External use (cream, shampoo, etc) per approved label is permitted.
- •5 Significant unrepaired structural left heart valvular disease (ie, moderate or severe
- •aortic or mitral stenosis or regurgitation); pericardial constriction; restrictive or
- •congestive left-sided cardiomyopathy; life-threatening cardiac arrhythmias; significant
- •left ventricular dysfunction; or left ventricular outflow obstruction
- •6 Known or suspected pulmonary veno-occlusive disease (PVOD)
- •7 Permanent atrial fibrillation or atrial flutter, in the opinion of the investigator.
- •8 Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history.
研究者
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