Efficacy and safety of LCZ696 compared to placebo in patients with essential hypertension

A multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of LCZ696 compared to placebo after 8 weeks treatment in patients with essential hypertension

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221236

Enrollment

392

Registered

2010-09-07

Start date

2010-09-07

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

Essential hypertension

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 must give written informed consent before any assessment is performed. 2.Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure >= 95 mmHg and = 140 mmHg and < 180 mmHg). 3.Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment. 4.Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.

Exclusion criteria

Exclusion criteria: 1.Patients with severe hypertension. 2.Patients with history of angioedema, drug-related or otherwise 3.Pregnant or nursing women 4.Women of child-bearing potential , who do not use adequate birth control methods 5.History or evidence of a secondary form of hypertension. 6.History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease. 7.Diabetes mellitus. 8.Previous or current diagnosis of heart failure (NYHA Class II-IV). 9.Clinically significant valvular heart disease at the time of screening. Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Mean sitting diastolic blood pressure Reduction in mean sitting diastolic blood pressure after 8 weeks treatment	—

Secondary

Measure	Time frame
Mean sitting systolic blood pressure Reduction in mean sitting systolic blood pressure after 8 weeks treatment Safety and tolerability Frequency of adverse events, serious adverse events, and notable laboratory abnormalities on baseline and after 8 weeks treatment Office and ambulatory pulse pressure Changes in office and ambulatory pulse pressure after 8 weeks treatment Ambulatory blood pressure Changes in mean 24 hour, mean daytime and mean nighttime diastolic blood pressure and systolic blood pressure	—

Measure

Time frame

Mean sitting systolic blood pressure Reduction in mean sitting systolic blood pressure after 8 weeks treatment Safety and tolerability Frequency of adverse events, serious adverse events, and notable laboratory abnormalities on baseline and after 8 weeks treatment Office and ambulatory pulse pressure Changes in office and ambulatory pulse pressure after 8 weeks treatment Ambulatory blood pressure Changes in mean 24 hour, mean daytime and mean nighttime diastolic blood pressure and systolic blood pressure

—

Outcome results

None listed

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