Overview

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
LCZ 696
Olmesartan
Olmesartan Medoxomil
Sacubitril and valsartan sodium hydrate drug combination
Criteria
Inclusion Criteria:

- Patients must give written informed consent before any assessment is performed

- Patients with essential hypertension, untreated or currently taking antihypertensive
therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg

- Patients must be able to communicate and comply with all study requirements and
demonstrate good medication compliance

Exclusion criteria:

- Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients
with history of angioedema, drug-related or otherwise

- Patients with history or evidence of a secondary form of hypertension

- Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any
history of stroke

- History of myocardial infarction, coronary bypass surgery or any percutaneous coronary
intervention (PCI) during the 12 months prior to Visit 1.

- Current angina pectoris requiring medication (other than patients on a stable dose of
oral or topical nitrates).

- Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are
not on a stable dose of antidiabetic medication

- Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).

- Patients with a clinically significant valvular heart disease at the time of screening

- Women of child-bearing potential, who do not use adequate birth control methods Other
protocol-defined inclusion/exclusion criteria may apply