Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
NCT ID: NCT01876368
Last Updated: 2015-12-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
376 participants
INTERVENTIONAL
2013-09-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LCZ696 200 mg
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
LCZ696
Placebo of LCZ696
Olmesartan 20 mg
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Olmesartan
Placebo of Olmesartan
Interventions
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LCZ696
Olmesartan
Placebo of LCZ696
Placebo of Olmesartan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
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
Ciudad Autonoma de Bs As, Buenos Aires, Argentina
Novartis Investigative Site
Caba, Buenos Aires F.D., Argentina
Novartis Investigative Site
Corrientes, Corrientes Province, Argentina
Novartis Investigative Site
Posadas, Misiones Province, Argentina
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, Guatemala
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, Guatemala
Novartis Investigative Site
Quezon City, Manila, Philippines
Novartis Investigative Site
Manila, National Capital Region, Philippines
Novartis Investigative Site
Quezon City, , Philippines
Novartis Investigative Site
Quezon City, , Philippines
Novartis Investigative Site
Manatí, , Puerto Rico
Novartis Investigative Site
Ponce, , Puerto Rico
Novartis Investigative Site
Ponce, , Puerto Rico
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saratov, , Russia
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Centelles, Catalonia, Spain
Novartis Investigative Site
Hostalets de Balenya, Catalonia, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Alzira, Valencia, Spain
Countries
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Other Identifiers
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2013-001783-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCZ696A2318
Identifier Type: -
Identifier Source: org_study_id