Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

Key facts

Study ID

NCT00549770

Run by

Novartis Pharmaceuticals

People needed

1334

Starts

2007-09-01

Expected to finish

2008-07-01

Last updated by the study team

2015-08-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or females from 18 up to and including 75 years
• Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
• Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
• Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);

You may not qualify if…

• Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
• History of angioedema, drug-related or otherwise, as reported by the patient
• Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
• History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
• History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease

Where it is running

• Novartis Investigative Site — Muscle Shoals, Alabama, United States
• Novartis Investigative Site — Chandler, Arizona, United States
• Novartis Investigative Site — Buena Park, California, United States
• Novartis Investigative Site — Fair Oaks, California, United States
• Novartis Investigative Site — Long Beach, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Orangevale, California, United States
• Novartis Investigative Site — Santa Ana, California, United States
• Novartis Investigative Site — Stockton, California, United States
• Novartis Investigative Site — Tustin, California, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Pembroke Pines, Florida, United States
• Novartis Investigative Site — Pembroke Pines, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Augusta, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Peoria, Illinois, United States
• Novartis Investigative Site — Baton Rouge, Louisiana, United States
• Novartis Investigative Site — Metairie, Louisiana, United States
• Novartis Investigative Site — Chelsea, Michigan, United States
• Novartis Investigative Site — Royal Oak, Michigan, United States
• Novartis Investigative Site — Brooklyn Center, Minnesota, United States
• Novartis Investigative Site — City of Saint Peters, Missouri, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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