Status:
COMPLETED
Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT01876368
Start Date
September 1 2013
End Date
August 1 2014
Last Update
December 7 2015
Active Locations (51)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35294-2041
2
Novartis Investigative Site
Fair Oaks, California, United States, 95628
3
Novartis Investigative Site
Hawaiian Gardens, California, United States, 90716
4
Novartis Investigative Site
Long Beach, California, United States, 90806