Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03066804 | A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients | PHASE3 | COMPLETED | 2,572 | — | — | Aug 22, 2017 | Oct 28, 2019 | Oct 11, 2021 | 380 | United States, Argentina +30 |
To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT-proBNP from baseline at Week 12 in patients with HFpEF
Change from baseline in 6-minute walk distance (6MWD) will be reported at Week 24. The 6 MWT will be performed in accordance with the guidelines of the American Thoracic Society 2002.
| Arm | Type | Description |
|---|---|---|
| sacubitril/valsartan (LCZ696) | EXPERIMENTAL | All patients who fulfill the inclusion/exclusion criteria will be stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi. Patients in the ACEi strata will receive LCZ696 or enalapril. Patients in the ARB strata will receive LCZ696 or valsartan. Patients in the no RASi strata will receive LCZ696 or matching placebo. Patients in the ACEi and ARB strata will take two pills twice daily for each dose: one tablet from the LCZ696 pack and one tablet from the comparator pack. Patients in the no RASi strata will take only one tablet twice daily (LCZ696 or matching placebo). In the LCZ696 arm, patients will receive active LCZ696 in titrated doses from level 1 up to level 3 (50 mg, 100 mg and 200 mg twice daily orally). |
| Comparator | ACTIVE_COMPARATOR | Patients randomized to the comparator arm will receive either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum). Patients in the ACE stratum randomized to comparator, will receive enalapril in titrated doses from level 1 up to level 3 (2.5 mg, 5 mg and 10 mg twice daily). Patients in the ARB stratum randomized to comparator will receive valsartan in titrated doses from level 1 up to level 3 (40 mg , 80 mg and 160 mg twice daily). Patients in the no RASi stratum randomized to comparator will receive LCZ696 matching placebo. |
| Name | Type | Description |
|---|---|---|
| sacubitril/valsartan | DRUG | Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally |
| Enalapril | DRUG | Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally |
| Valsartan | DRUG | Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally |
| Placebo to match sacubitril/valsartan | DRUG | Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally |
| Placebo to match enalapril | DRUG | Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally |
| Placebo to match valsartan | DRUG | Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally |
Inclusion Criteria: * Left ventricular ejection fraction (LVEF) \>40% by echo within 6 months prior to study entry or during the screening epoch * Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist \[MRAs\]) fo...