Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension

A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222043

Enrollment

432

Registered

2013-03-18

Start date

2013-03-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Pressure

Interventions

investigational material(s) Generic name etc : LCZ696 INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : once

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with essential hypertension, untreated or currently taking antihypertensive therapy. 2.Untreated patients must have an office msSBP >=150 mmHg and =140 mmHg and =150 mmHg and 60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP. 5.Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201.

Exclusion criteria

Exclusion criteria: 1.Malignant or severe hypertension (grade 3 of WHO classification; msDBP >=110 mmHg and/or msSBP >=180 mmHg) 2.History of angioedema, drug-related or otherwise. 3.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. 4.Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke. 5.History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. 6.History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening. Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Change from baseline in mean central aortic systolic blood pressure at 12 weeks [ Time Frame: baseline, 12 weeks ]	—

Secondary

Measure	Time frame
Change from baseline in mean central pulse pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean aortic pulse wave velocity [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean central aortic systolic blood pressure at 52 weeks [ Time Frame: baseline, 52 weeks ] Change from baseline in mean sitting systolic blood pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean sitting diastolic blood pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean sitting pulse pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean arterial pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean 24-hour systolic blood pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean 24-hour diastolic blood pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean 24-hour ambulatory pulse pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ]	—

Measure

Time frame

Change from baseline in mean central pulse pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean aortic pulse wave velocity [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean central aortic systolic blood pressure at 52 weeks [ Time Frame: baseline, 52 weeks ] Change from baseline in mean sitting systolic blood pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean sitting diastolic blood pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean sitting pulse pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean arterial pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean 24-hour systolic blood pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean 24-hour diastolic blood pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ] Change from baseline in mean 24-hour ambulatory pulse pressure [ Time Frame: baseline, 12 weeks, and 52 weeks ]

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026