Phase 3
Completed N=588
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
Source: ClinicalTrials.gov NCT01615198 ↗Enrolled (actual)
588
Serious AEs
1.5%
Results posted
Aug 2015
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) — -22.71; -16.11 mmHg
Summary
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) |
-22.71; -16.11 | — |
| SECONDARY Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) |
-14.23; -9.14 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) |
-17.64; -15.81; -6.08; -5.58; -22.53; -16.75 | — |
| SECONDARY Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) |
-6.95; -4.47 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) |
-8.58; -6.49 | — |
| SECONDARY Change From Baseline in Mean Sitting Pulse Pressure |
-11.57; -10.38; -14.21; -9.76; -14.65; -10.90 | — |
| SECONDARY Change From Baseline in Daytime and Nighttime maSBP/maDBP |
-14.32; -10.02; -13.97; -7.68; -7.04; -4.88 | — |
| SECONDARY Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers |
-18.48; -14.15; -20.75; -17.26; -17.44; -12.65 | — |
| SECONDARY Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers |
-13.42; -9.53; -15.60; -8.57; -13.17; -6.33 | — |
| SECONDARY Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) |
140; 120; 175; 130; 173; 126 | — |
| SECONDARY Number of Participants Achieving Successful Response in msSBP and msDBP |
162; 146; 208; 142; 205; 144 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Death |
141; 113; 7; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must give written informed consent before any assessment is performed
- Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg
- Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance
Exclusion criteria
- Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
- Patients with history or evidence of a secondary form of hypertension
- Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
- History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
- Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
- Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
- Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
- Patients with a clinically significant valvular heart disease at the time of screening
- Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01615198). 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.