Phase 3
Completed N=1,161
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
Source: ClinicalTrials.gov NCT01599104 ↗Enrolled (actual)
1,161
Serious AEs
0.8%
Results posted
Aug 2015
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) — -18.21; -20.18; -13.20 mmHg
Summary
This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) |
-18.21; -20.18; -13.20 | — |
| SECONDARY Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 |
-13.44; -14.99; -8.78 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) |
-7.76; -8.79; -5.91 | — |
| SECONDARY Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8 |
43.9; 46.5; 32.9 | — |
| SECONDARY Percentage of Participants Achieving a Successful msSBP Response |
57.9; 63.1; 42.9 | — |
| SECONDARY Percentage of Participants Achieving a Successful msDBP Response |
69.5; 70.1; 60.7 | — |
| SECONDARY Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8 |
-7.65; -8.44; -5.56 | — |
| SECONDARY Change From Baseline in maSBP and maDBP for Daytime/Nighttime |
-12.60; -14.44; -7.87; -15.13; -16.09; -10.65 | — |
| SECONDARY Change From Baseline in Office Pulse Pressure |
-10.49; -11.30; -7.34 | — |
| SECONDARY Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure |
-5.79; -6.57; -3.20 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events and Death |
135; 136; 152; 1; 1; 7 | — |
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 proceeding 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
- 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 (NCT01599104). 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.