Phase 3 Completed N=376 Randomized Double-blind Treatment

Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

Hypertension

Source: ClinicalTrials.gov NCT01876368 ↗

Enrolled (actual)

376

Serious AEs

0.5%

Results posted

Dec 2015

Primary outcomePrimary: Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) — -4.26; -1.04 mmHg — p=<0.001

Summary

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)	-4.26; -1.04	<0.001 sig
SECONDARY Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)	-2.27; -0.35	—
SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	-14.21; -10.03	—
SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	-7.52; -4.47	—
SECONDARY Change From Baseline in Office Pulse Pressure	-6.67; -5.54	—
SECONDARY Number of Patients Achieving Successful Overall Blood Pressure Control	76; 52	—
SECONDARY Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control	84; 58	—
SECONDARY Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control	133; 112	—
SECONDARY Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response	90; 65	—
SECONDARY Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response	137; 115	—
SECONDARY Number of Patients With Total Adverse Events, Serious Adverse Events and Death	44; 41; 0; 2; 0; 0	—

Eligibility Criteria

Inclusion Criteria

patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Exclusion Criteria

Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
History of angioedema, drug-related or otherwise
History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease (PKD), drug-induced hypertension
Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

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Data sourced from ClinicalTrials.gov (NCT01876368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.