Table 1.
Trials of combined angiotensin receptor antagonism/neprilysin inhibition with >100 patientsa.
| Trial Number | Title | Patient Population | Comparator | Results |
|---|---|---|---|---|
| NCT01035255 | Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure (PARADIGM-HF) | HFrEF (n=8442) | Enalapril | Published, Reference 45 |
| NCT00549770 | Efficacy and Safety of LCZ696A in Patients with Essential Hypertension | Essential Hypertension (n=1328) | Valsartan Sacubitril Placebo | Published, Reference 49 |
| NCT01193101 | Efficacy and Safety of LCZ696 Compared to Placebo in Patients with Essential Hypertension | Essential Hypertension (n=389) | Placebo | Published, Reference 50 |
| NCT00887588 | Prospective comparison of ARni with ARB on Management Of heart failUre with preserved ejectioN fracTion (PARAMOUNT) | HFpEF (n=301) | Valsartan | Published, Reference 6 |
| NCT01785472 | Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients with Essential Hypertension | Essential Hypertension (n=1438) | Olmesartan | Completed, no published results |
| NCT01599104 | Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients with Essential Hypertension | Essential Hypertension (n=1161) | Olmesartan | Completed, no published results |
| NCT01281306 | 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 | Essential Hypertension (n=915) | Valsartan Sacubitril Placebo | Completed, no published results |
| NCT01615198 | Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients with Essential Hypertension | Essential Hypertension (n=588) | Olmesartan | Completed, no published results |
| NCT01922089 | Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients (TITRATION) | HFrEF (n=498) | NA | Completed, no published results |
| NCT01692301 | Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension | Essential Hypertension (n=454) | Olmesartan | Completed, no published results |
| NCT01876368 | Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan | Essential Hypertension (n=374) | Olmesartan | Completed, no published results |
| NCT01256411 | A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension | Essential Hypertension (n=341) | NA | Completed, no published results |
| NCT01663233 | Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine | Essential Hypertension (n=266) | Amlodipine | Completed, no published results |
| NCT01920711 | Prospective comparison of ARni with Arb Global Outcomes in heart failure with preserved ejectioN fraction (PARAGON)-HF | HFpEF (n=4300)* | Valsartan | Currently Recruiting |
| NCT02226120 | Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction | HFrEF (n=3714)* | NA | Currently Recruiting |
| NCT02468232 | Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction | HFrEF (n=220)* | Enalapril | Currently Recruiting |
| NCT01870739 | A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension | Essential Hypertension (n=140)* | Olmesartan | Currently Recruiting |
a
Trials registered with ClinicalTrials.gov.
HFrEF indicates heart failure with reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; ARNI, angiotensin receptor neprilysin inhibitor; ACEI, angiotensin converting enzyme inhibitor; ARB, angiotensin receptor blocker; and NA, not applicable.
*
Estimated enrollment