Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertension

In brief

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Key facts

Study ID

NCT01876368

Run by

Novartis Pharmaceuticals

People needed

376

Starts

2013-09-01

Expected to finish

2014-08-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
• treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
• untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
• patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

You may not qualify if…

• Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
• History of angioedema, drug-related or otherwise
• History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease (PKD), drug-induced hypertension
• Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

Where it is running

• Novartis Investigative Site — Fair Oaks, California, United States
• Novartis Investigative Site — Hawaiian Gardens, 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 — Westlake Village, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Conyers, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Edina, Minnesota, United States
• Novartis Investigative Site — Belzoni, Mississippi, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Oregon City, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Varnville, South Carolina, United States
• Novartis Investigative Site — Richmond, Virginia, United States
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Caba, Buenos Aires, Argentina
• Novartis Investigative Site — Ciudad Autonoma de Bs As, Buenos Aires, Argentina
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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