Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2013 |
End Date: | August 2014 |
A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan
This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in
essential hypertensive patients not adequately responsive to olmesartan
essential hypertensive patients not adequately responsive to olmesartan
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
23
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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