Phase 3
Completed N=1,438
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension
Source: ClinicalTrials.gov NCT01785472 ↗Enrolled (actual)
1,438
Serious AEs
1.0%
Results posted
Sep 2015
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg — -20.48; -18.15 mmHg — p=<0.001
Summary
This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg |
-20.48; -18.15 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg |
-21.67; -18.15 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg |
-8.10; -8.80; -6.86 | — |
| SECONDARY Change From Baseline in Office Pulse Pressure (msPP) |
-12.35; -12.93; -11.25 | — |
| SECONDARY Change From Baseline in Mean 24-hour Ambulatory Blood Pressure |
-12.07; -12.76; -10.26; -6.36; -6.82; -5.61 | — |
| SECONDARY Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers. |
-13.22; -15.02; -9.07; -17.24; -18.11; -13.95 | — |
| SECONDARY Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers. |
-7.93; -7.38; -5.99; -8.47; -10.19; -10.49 | — |
| SECONDARY Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers. |
-11.29; -10.38; -9.37; -10.51; -11.07; -10.26 | — |
| SECONDARY Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers. |
-5.93; -6.57; -4.57; -5.41; -551; -5.49 | — |
| SECONDARY Number of Patients Achieving Successful Blood Pressure Control |
256; 270; 235 | — |
| SECONDARY Change From Baseline in Ambulatory Pulse Pressure |
-5.78; -5.98; -4.58 | — |
| SECONDARY Number of Responders |
312; 314; 290 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability |
143; 132; 134; 5; 3; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
- Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at the randomization visit (Visit 201) and msSBP≥140 mmHg <180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or 103).
- Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at both Visit 1 and Visit 201.
- Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit.
Exclusion Criteria
- Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).
- History of angioedema, drug-related or otherwise, as reported by the patient.
- 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, and drug-induced hypertension.
- Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01785472). 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.