Evaluating effects of LCZ696 in subjects with Essential Hypertension
Research type
Research Study
Full title
Randomized, double-blind, active-controlled, parallel group, 52-week study to evaluate the effects of LCZ696 compared to Olmesartan on regional aortic stiffness in subjects with essential hypertension
IRAS ID
131001
Contact name
Patrik Petterssson
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2012-005720-15
Clinicaltrials.gov Identifier
Research summary
Stiffness of the aorta, which is the main blood vessel arising from the heart results from progressive loss of the natural elasticity that is found in vessel wall. This occurs with age or as a result of cardiac diseases. The end result is an increase in systolic blood pressure (SBP) and in pulse pressure (the difference between systolic and diastolic BP), which are both associated with an increased risk of cardiac illness and death. More effective treatment of the systolic blood pressure aortic stiffness may improve health outcomes in patients with cardiovascular disease. This remains a challenge as, while there are effective treatments available for treating high blood pressure (hypertension), there are no current treatments available that both reduce high blood pressure and stop or slow down the process of increasing aortic stiffness in the major arteries of the body.
LCZ696 is a first-in-class angiotensin receptor neprilysin inhibitor (ARNI) that is being developed for the treatment of a range of cardiovascular diseases, including hypertension and heart failure. It works by blocking the hormone called angiotensin II and increasing the blood levels of hormones called natriuretic peptides. We hypothesize that this dual action will reduce both blood pressure and aortic stiffness. This hypothesis is supported by the findings from other recent clinical trials, which suggest that LCZ696 can reduce high blood pressure and improve aortic stiffness, which could in turn reduce kidney, heart and brain damage.
The study will comprise 4 periods– over 52 weeks. An interim analysis is planned after approximately 128 participants from the United Kingdom, Germany and Switzerland have been enrolled and have completed the core study period. Participants will be required to attend 11 study visits over the course of one year.
REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/1097
Date of REC Opinion
11 Sep 2013
REC opinion
Further Information Favourable Opinion