Clinical trials: Sacubitril/Valsartan
Chronic Heart Failure (CHF)
Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
This study was a multi-center, randomized, double-blind, parallel group, active comparator trial designed to evaluate the overall effect of LCZ696 compared to valsartan on cognitive function as assessed by the CogState…
- Trial name
- PERSPECTIVE (NCT02884206)
- Testing
- LCZ696, Valsartan
- Where
- 135 sites in United States, Argentina and 18 more
- Volunteers
- 592 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Systolic
Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes…
- Trial name
- PROVIDE-HF (NCT03387163)
- Testing
- Sacubitril/Valsartan
- Where
- United States
- Volunteers
- 402 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the…
- Trial name
- TurkuPET (NCT03300427)
- Testing
- sacubitril/valsatran, valsartan
- Where
- Finland
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2…
- Trial name
- NCT03785405
- Testing
- sacubitril/valsartan
- Where
- 79 sites in United States, Argentina and 25 more
- Volunteers
- 216 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
The purpose of this open-label study was to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed…
- Trial name
- NCT06149104
- Testing
- sacubitril/valsartan
- Where
- 6 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Primary Hypertension
Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets
This study aims to evaluate the bioequivalence and safety of single oral administration of Sacubitril/Valsartan/Amlodipine Tablets (240mg/5mg) versus Sacubitril/Valsartan Calcium Tablets (240mg) combined with Amlodipine Besylate…
- Trial name
- NCT07486453
- Testing
- Sequence A T-R-T-R, Sequence B R-T-R-T
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Heart Failure
Real World Experience in Heart Failure With Reduced Ejection Fraction (HFrEF) Patients Treated With sAc/vaL.
The study is a cohort observational, retrospective, non-interventional study.
- Trial name
- NCT05448872
- Testing
- Sacubitril/Valsartan
- Where
- Italy
- Volunteers
- 924 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates
The aim of this study is to evaluate the real-world effectiveness of ARNi (sacubitril/valsartan) therapy and antihypertensive monotherapy in reducing blood pressure in hypertensive patients residing in the United Arab Emirates.
- Trial name
- REAL-HTN (NCT07465666)
- Where
- 4 sites in United Arab Emirates
- Volunteers
- 500 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
A Real-world Study to Compare the Effectiveness of Sacubitril/Valsartan Versus ACEi/ARB in HFrEF Patients
This was a retrospective, observational, comparative cohort study using secondary data from electronic health records (EHR) from a local health unit that provides primary, secondary and tertiary care to a resident population in…
- Trial name
- NCT07376265
- Where
- United States
- Volunteers
- 1,249 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)
Secondary Use of PARALLEL-HF Data
This study utilized the blood and first morning void (FMV) urine samples from the PARALLEL-HF study (core part). The PARALLEL-HF study (core part) was a multicenter, randomized, double-blind, double-dummy, parallel-group…
- Trial name
- NCT07527767
- Where
- Japan
- Volunteers
- 236 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
This is a single arm, multicenter, observational study to evaluate the safety and efficacy of Entresto Tablets during the first 52 weeks of treatment in Japanese patients with hypertension.
- Trial name
- ENLIGHT (NCT05976230)
- Testing
- Entresto
- Where
- 117 sites in Japan
- Volunteers
- 1,125 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Heart Failure
Bioequivalence Study to Compare Sacubitril and Valsartan Tablets (97mg/103mg) Versus Entresto® (Sacubitril and Valsartan) Tablets (97 mg/103 mg)
An open label, balanced, randomized, single dose, two treatment, two sequence, four period, full-replicate, oral bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of HUMANİS SAĞLIK ANONİM ŞİRKETİ Ç.O.S.B.…
- Trial name
- NCT06922253
- Testing
- Sacubitril and Valsartan-Test product, Sacubitril and Valsartan-Reference product
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
Essential Hypertension
Assess Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine
The main objective of the study will be to assess the efficacy and safety of Sacubitril/Allisartan (240mg) and Amlodipine (5mg) in patients with essential hypertension uncontrolled after 4-week treatment with Amlodipine (5mg).
- Trial name
- NCT07704684
- Testing
- Experimental: Sacubitril/Allisartan and Amlodipine Group, Active Comparator: Amlodipine Group
- Where
- China
- Volunteers
- 376 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Essential Hypertension
QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension
The purpose of the study is to evaluate the efficacy and safety of QR12000 75mg, QR12000 150mg and Sacubitril/valsartan 200mg in patients with moderate to severe essential hypertension.
- Trial name
- NCT06716970
- Testing
- QR12000 75mg, QR12000 150mg, Sacubitril/valsartan 200mg
- Where
- China
- Volunteers
- 810 people
- Sponsor
- Wuhan Createrna Science and Technology Co., Ltd
Chagas Disease, Heart Failure
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC
The purpose of this study was to evaluate the effect of sacubitril/valsartan 200 mg BID compared with enalapril 10 mg BID, in addition to conventional heart failure (HF) treatment, in improving a hierarchical composite of…
- Trial name
- PARACHUTE-HF (NCT04023227)
- Testing
- Sacubitril/valsartan, Enalapril
- Where
- 79 sites in Argentina, Brazil and 2 more
- Volunteers
- 922 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure With Preserved Ejection Fraction
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
- Trial name
- PARAGON-HF (NCT01920711)
- Testing
- LCZ696, Valsartan
- Where
- 715 sites in United States, Argentina and 41 more
- Volunteers
- 4,822 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure With Reduced Ejection Fraction
A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan
The aim of this study was to describe the real-world clinical profile, treatment patterns, and guideline alignment of patients with heart failure with reduced ejection fraction (HFrEF) treated with sacubitril/valsartan in routine…
- Trial name
- REACT-HFrEF-RO (NCT07465679)
- Where
- Romania
- Volunteers
- 2,508 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure With Reduced Ejection Fraction
A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction…
- Trial name
- NCT07465653
- Testing
- HJB647 low dose, HJB647 high dose
- Where
- 6 sites in United States, Canada
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Salt-sensitive Hypertension
Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
- Trial name
- NCT01681576
- Testing
- Valsartan, LCZ696
- Where
- 15 sites in United States, Hong Kong and 3 more
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals