DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: LCZ696 (Drug); Olmesartan (Drug); LCZ696 matching placebo (Drug); Olmesartan matching placebo (Drug); amlodipine (Drug); hydrochlorothiazide (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in mean central aortic systolic blood pressure at 12 weeks

Secondary outcome:

Change from baseline in mean central pulse pressure

Change from baseline in mean aortic pulse wave velocity

Change from baseline in mean central aortic systolic blood pressure at 52 weeks

Change from baseline in mean sitting systolic blood pressure

Change from baseline in mean sitting diastolic blood pressure

Change from baseline in mean sitting pulse pressure

Change from baseline in mean arterial pressure

Change from baseline in mean 24-hour systolic blood pressure

Change from baseline in mean 24-hour diastolic blood pressure

Change from baseline in mean 24-hour ambulatory pulse pressure

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Novartis Investigative Site, Barranquilla, Colombia

Novartis Investigative Site, Paris 75015, France

Novartis Investigative Site, Berlin 10117, Germany

Novartis Investigative Site, Nuernberg 90471, Germany

Novartis Investigative Site, Athens 11525, Greece

Novartis Investigative Site, Athens 11526, Greece

Novartis Investigative Site, Moscow 101990, Russian Federation

Novartis Investigative Site, Moscow 117198, Russian Federation

Novartis Investigative Site, Moscow 119992, Russian Federation

Novartis Investigative Site, Saint-Petersburg 197341, Russian Federation

Novartis Investigative Site, Sankt-Peterburg 197022, Russian Federation

Novartis Investigative Site, Yaroslavl 150047, Russian Federation

Novartis Investigative Site, Madrid 28034, Spain

Novartis Investigative Site, Madrid 28041, Spain

Novartis Investigative Site, Taichung 40447, Taiwan

Novartis Investigative Site, Taipei 114, Taiwan

Novartis Investigative Site, Jerez de La Frontera, Andalucia 11407, Spain

Novartis Investigative Site, Sevilla, Andalucia 41071, Spain

Novartis Investigative Site, Barranquilla, Atlantico, Colombia

Novartis Investigative Site, Treviglio, BG 24047, Italy

Novartis Investigative Site, Caba, Buenos Aires C1440AAD, Argentina

Novartis Investigative Site, Ramos Mejia, Buenos Aires B1704ETD, Argentina

Novartis Investigative Site, Barcelona, Cataluna 08003, Spain

Novartis Investigative Site, Barcelona, Catalunya 08025, Spain

Novartis Investigative Site, Centelles, Cataluña 08540, Spain

Novartis Investigative Site, Terrassa, Cataluña 08221, Spain

Novartis Investigative Site, Puerto de Sagunto, Comunidad Valenciana 46520, Spain

Novartis Investigative Site, Clearwater, Florida 33756, United States

Novartis Investigative Site, Thessaloniki, GR 546 42, Greece

Novartis Investigative Site, La Coruna, Galicia 15706, Spain

Novartis Investigative Site, Bucheon, Gyeonggi-do 424-717, Korea, Republic of

Novartis Investigative Site, Chicago, Illinois 60607, United States

Novartis Investigative Site, Seoul, Korea 110 744, Korea, Republic of

Novartis Investigative Site, Baltimore, Maryland 21204, United States

Novartis Investigative Site, Belzoni, Mississippi 39038, United States

Novartis Investigative Site, Jackson, Mississippi 39209, United States

Novartis Investigative Site, St. Louis, Missouri 63141, United States

Novartis Investigative Site, Buffalo, New York 14215, United States

Novartis Investigative Site, Cincinnati, Ohio 45224, United States

Novartis Investigative Site, Pisa, PI 56126, Italy

Novartis Investigative Site, Rosario, Santa Fe S2000CXH, Argentina

Novartis Investigative Site, Taipei, Taiwan, ROC 112, Taiwan

Novartis Investigative Site, Houston, Texas 77081, United States

Novartis Investigative Site, Lake Jackson, Texas 77566, United States

Novartis Investigative Site, Pasadena, Texas 77504, United States

Novartis Investigative Site, Shimotsuke-city, Tochigi 329-0498, Japan

Novartis Investigative Site, San Daniele Del Friuli, UD 33038, Italy

Additional Information

Starting date: December 2012
Last updated: April 7, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017