Status:
COMPLETED
Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Shanghai Zhongshan Hospital
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This multicenter, open label, single-arm study is aim at investigating the the efficacy and safety of china made ambrisentan in Chinese subjects with PAH.
Detailed Description
Pulmonary arterial hypertension is a hemodynamic and pathophysiological state, which can cause progressive hyperplasia of pulmonary vascular walls and elevated pulmonary arterial pressure for various ...
Eligibility Criteria
Inclusion
- Age ≥18 years old and ≤75 years old, regardless of gender;
- patients weighing ≥ 40 kg;
- Patients diagnosed with PAH in Group 1 of the WHO Updated Clinical Classification of Pulmonary Hypertension (WHO functional class II or III);
- 6 min walk test (6MWT), walking distance ≥ 50 m;
- Right heart catheterization performed within 6 months prior to screening and meeting the following hemodynamic criteria:
- mean pulmonary artery pressure ≥ 25 mm Hg；
- Pulmonary vascular resistance ≥ 240 dyn·s·cm-5;
- Pulmonary artery wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg;
- Subject receiving calcium channel blocker (CCB) drugs, only those whose doses have been stabilized for more than 4 weeks at the time of screening are allowed to be included in the study;
- Pulmonary function testing performed within 6 months prior to screening and meeting the following criteria：
- Total lung capacity ≥ 60% of normal predicted value;
- Forced expiratory volume in one second (FEV1) ≥ 55% of normal expected value;
- Female subjects of childbearing potential must have a negative pregnancy test at the Screening Visit and Day 0;
- Females subjects of childbearing potential must use a medically acceptable method of contraception (eg, hormone therapy, IUD, barrier methods such as condoms or cervical caps) during the study;
- Sign written informed consent
Exclusion
- Patients diagnosed with WHO updated PH clinical classification of group 2, 3, 4, 5;
- Endothelin receptor antagonist therapy (eg, bosentan) has been discontinued prior to enrollment due to safety or tolerability concerns (non-drug-induced liver function abnormalities);
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 2 times ULN;
- Serum bilirubin level \> 1.5 times ULN;
- severe hepatic insufficiency (Child-Pugh class C);
- severe renal insufficiency (creatinine clearance \<30 mL/min);
- Hemoglobin concentration \< 10 g/dL or hematocrit \< 30%;
- Contraindications to treatment identified by laboratory tests, physical examination, medical history, or other investigations
- severe hypotension (diastolic \< 50 mm Hg or systolic \< 90 mm Hg);
- Clinically significant aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, fatal arrhythmias, LV ejection fraction \< 45%, LV outflow tract obstruction, symptomatic coronary heart disease, spontaneously low blood pressure;
- A history of malignancy within 5 years prior to enrollment, except for basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Subject taking endothelin receptor antagonists such as ambrisentan, bosentan and macitentan within 4 weeks prior to enrollment;
- pregnant and lactating women;
- Subject deemed unsuitable for participation in this study by other investigators
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05437224
Start Date
December 18 2018
End Date
February 6 2022
Last Update
June 29 2022
Active Locations (1)
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1
Renji Hospital
Shanghai, China, 200127