Phase IV study to evaluate safety and efficacy of Pulmosil (Sildenafil Injection) for the treatment of pulmonary arterial hypertension in India.

Sun Pharmaceutical Industries Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•Subjects must meet all of the following criteria to be considered for
•enrollment in the study:
•1. Patients aged 18 to 65 years with confirmed diagnosis of Pulmonary arterial hypertension, who are on oral sildenafil and temporarily require (at least 3 days) intravenous sildenafil as per investigators discretion (eg. Clinical worsening).
•2.Patients or his/her legally acceptable representative willing to give their informed consent.

•Subjects meeting any of the following criteria must be excluded from
•enrollment in the study:
•Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
•2. Patients with uncorrected congenital heart disease and PAH.
•3. Patients with pulmonary hypertension due to thromboembolism.
•4. Patients with pulmonary hypertension secondary to sickle cell disease.
•Patients with HIV.
•6. Patients with chronic obstructive airway disease.
•7. Patients with congestive heart failure (NYH III and IV) or stroke, or life-threatening arrhythmia.
•8. Patients with coronary artery disease causing unstable angina.
•9. Patients with hypertension (BP >170/110).
•10. Patients with schistosomiasis.
•Patients with significant (i.e., >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days.
•12. Patients with resting hypotension [ BP < 90/50] or fluid depletion or severe left ventricular outflow obstruction, or autonomic dysfunction or veno-occlusive disease.
•13. Patients with bleeding disorders or active peptic ulcer.
•14. Patients who are using Alpha-adrenergic blocking agents.
•15. Patients who are taking nitrates in any form, either regularly or intermittently.

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