Overview

A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Amlodipine
LCZ 696
Olmesartan
Olmesartan Medoxomil
Sacubitril and valsartan sodium hydrate drug combination
Valsartan
Criteria
Key Inclusion Criteria:

- Subjects with essential hypertension, untreated or currently taking antihypertensive
therapy

Key exclusion Criteria:

- women of child bearing potential (WOCBP) if not on highly effective contraception

- Malignant or severe hypertension (grade 3 of WHO classification)

- History or evidence of a secondary form of hypertension

- Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or
any history of stroke.

- Previous or current diagnosis of heart failure (New York Heart Association Class
II-IV).