A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1. Signed informed consent must be obtained prior to participation in the study.
•2. Patient was on study medication at the PANORAMA-HF Part 2 End of Study visit (Visit 416) and does not have any significant safety issue as determined by the investigator. Based on the investigator judgement, the patient is able to safely enroll in the OLE study.

•1. Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2
•2. Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires more than or equal to 36-hour washout before baseline visit)
•3. History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan
•4. Renal vascular hypertension (including renal artery stenosis)
•5. Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula less than 30 percent mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase more than 3 times upper limit of normal); gastrointestinal disorder or biliary disorder
•6. History of angioedema

发起方

ovartis Healthcare Pvt Ltd