Hypertension Clinical Trial
Official title:
A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension
To examine the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).
Status | Completed |
Enrollment | 454 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: 1. Male and female patients = 60 years of age. 2. Patients with essential hypertension, untreated or currently taking antihypertensive therapy. 3. Untreated patients must have an office msSBP =150 mmHg and <180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1. 4. Treated patients must have an office msSBP =140 mmHg and <180 mmHg at Visit 102 (or Visit 103) and msSBP =150 mmHg and <180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1. 5. All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP. 6. Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201. Exclusion Criteria: 1. Malignant or severe hypertension (grade 3 of WHO classification; msDBP =110 mmHg and/or msSBP = 180 mmHg) 2. History of angioedema, drug-related or otherwise. 3. 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, and drug-induced hypertension. 4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke. 5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. 6. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening. Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Argentina | Novartis Investigative Site | Ramos Mejia | Buenos Aires |
Argentina | Novartis Investigative Site | Rosario | Santa Fe |
Colombia | Novartis Investigative Site | Barranquilla | Atlantico |
Colombia | Novartis Investigative Site | Barranquilla | |
France | Novartis Investigative Site | Paris | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Nuernberg | |
Greece | Novartis Investigative Site | Athens | |
Greece | Novartis Investigative Site | Athens | |
Greece | Novartis Investigative Site | Thessaloniki | GR |
Italy | Novartis Investigative Site | Pisa | PI |
Italy | Novartis Investigative Site | San Daniele Del Friuli | UD |
Italy | Novartis Investigative Site | Treviglio | BG |
Japan | Novartis Investigative Site | Shimotsuke-city | Tochigi |
Korea, Republic of | Novartis Investigative Site | Bucheon | Gyeonggi-do |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Saint-Petersburg | |
Russian Federation | Novartis Investigative Site | Sankt-Peterburg | |
Russian Federation | Novartis Investigative Site | Yaroslavl | |
Spain | Novartis Investigative Site | Barcelona | Cataluna |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Centelles | Cataluña |
Spain | Novartis Investigative Site | Jerez de La Frontera | Andalucia |
Spain | Novartis Investigative Site | La Coruna | Galicia |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Puerto de Sagunto | Comunidad Valenciana |
Spain | Novartis Investigative Site | Sevilla | Andalucia |
Spain | Novartis Investigative Site | Terrassa | Cataluña |
Taiwan | Novartis Investigative Site | Taichung | |
Taiwan | Novartis Investigative Site | Taipei | |
Taiwan | Novartis Investigative Site | Taipei | Taiwan, ROC |
United States | Novartis Investigative Site | Baltimore | Maryland |
United States | Novartis Investigative Site | Belzoni | Mississippi |
United States | Novartis Investigative Site | Buffalo | New York |
United States | Novartis Investigative Site | Chicago | Illinois |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Clearwater | Florida |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Jackson | Mississippi |
United States | Novartis Investigative Site | Lake Jackson | Texas |
United States | Novartis Investigative Site | Pasadena | Texas |
United States | Novartis Investigative Site | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Argentina, Colombia, France, Germany, Greece, Italy, Japan, Korea, Republic of, Russian Federation, Spain, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in mean central aortic systolic blood pressure at 12 weeks | baseline, 12 weeks | No | |
Secondary | Change from baseline in mean central pulse pressure | baseline, 12 weeks, and 52 weeks | No | |
Secondary | Change from baseline in mean aortic pulse wave velocity | baseline, 12 weeks, and 52 weeks | No | |
Secondary | Change from baseline in mean central aortic systolic blood pressure at 52 weeks | baseline, 52 weeks | No | |
Secondary | Change from baseline in mean sitting systolic blood pressure | baseline, 12 weeks, and 52 weeks | No | |
Secondary | Change from baseline in mean sitting diastolic blood pressure | baseline, 12 weeks, and 52 weeks | No | |
Secondary | Change from baseline in mean sitting pulse pressure | baseline, 12 weeks, and 52 weeks | No | |
Secondary | Change from baseline in mean arterial pressure | baseline, 12 weeks, and 52 weeks | No | |
Secondary | Change from baseline in mean 24-hour systolic blood pressure | baseline, 12 weeks, and 52 weeks | No | |
Secondary | Change from baseline in mean 24-hour diastolic blood pressure | baseline, 12 weeks, and 52 weeks | No | |
Secondary | Change from baseline in mean 24-hour ambulatory pulse pressure | baseline, 12 weeks, and 52 weeks | No |
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