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

Phase 2

• Conditions: Essential hypertension

• Registration Number: JPRN-jRCT2080221236
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 392

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 < 110 mmHg, and mean sitting systolic blood pressure >= 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean sitting diastolic blood pressure<br>Reduction in mean sitting diastolic blood pressure after 8 weeks treatment

Secondary Outcome Measures

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