Clinical trials: Sacubitril/Valsartan
de Novo Heart Failure
Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients
This was a non-interventional retrospective cohort study of de novo heart failure with reduced ejection fraction (HFrEF) patients (aged ≥18 years) commencing first-line treatment on either sacubitril/valsartan or commencing or…
- Trial name
- NCT05963282
- Where
- United States
- Volunteers
- 9,870 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Heart Failure
Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S…
- Trial name
- NCT05613140
- Testing
- sacubitril/valsartan
- Where
- United States
- Volunteers
- 9,230 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Heart Failure With Reduced Ejection Fraction
randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure
The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary…
- Trial name
- OUTSTEP-HF (NCT02900378)
- Testing
- LCZ696 (Sacubitril/Valsartan), Enalapril
- Where
- 119 sites in Belgium, Bulgaria and 17 more
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Subjects
Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06248112
- Testing
- Sacubitril and Valsartan-Test product, Sacubitril and Valsartan-Reference product
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
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.
Systolic Hypertension
An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension
The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).
- Trial name
- NCT01281306
- Testing
- LCZ696, Valsartan, AHU377
- Where
- 90 sites in United States, Argentina and 7 more
- Volunteers
- 910 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
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 With Preserved Ejection Fraction (HFpEF)
Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days…
- Trial name
- PARAGLIDE-HF (NCT03988634)
- Testing
- sacubitril/valsartan, valsartan
- Where
- 97 sites in United States, Canada
- Volunteers
- 467 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
Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan…
- Trial name
- NCT04735354
- Testing
- sacubitril/valsartan
- Where
- India
- Volunteers
- 268 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Heart Failure
Impact of Formulary Coverage of Entresto (Sacubitril/Valsartan) on Prescription Abandonment/Rejection and Subsequent Treatment and Economic Outcomes in Chronic Heart Failure Patients in the U.S.
This was a retrospective cohort study utilizing IQVIA open-source pharmacy and medical claims data among patients with a sacubitril/valsartan (SAC/VAL) prescription transaction.
- Trial name
- NCT05848206
- Where
- United States
- Volunteers
- 251,831 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure With Preserved Ejection Fraction
A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients
The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF…
- Trial name
- PARALLAX (NCT03066804)
- Testing
- sacubitril/valsartan, Enalapril, Valsartan
- Where
- 380 sites in United States, Argentina and 30 more
- Volunteers
- 2,572 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 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
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
Chronic Heart Failure
Special Drug Use Surveillance for Entresto Tablets
This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.
- Trial name
- NCT04781881
- Testing
- Entresto
- Where
- 121 sites in Japan
- Volunteers
- 688 people
- Sponsor
- Novartis Pharmaceuticals
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
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.
Heart Failure, Reduced Ejection Fraction
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
The purpose of this study was to investigate the effects of initiation of sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and sleep in subjects with heart failure with reduced ejection…
- Trial name
- AWAKE-HF (NCT02970669)
- Testing
- sacubitril/valsartan (LCZ696), enalapril
- Where
- 23 sites in United States
- Volunteers
- 140 people
- Sponsor
- Novartis Pharmaceuticals