Efficacy and Safety of LCZ696A in Patients With Essential Hypertension - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00549770

Purpose

This study is a proof of efficacy dose ranging study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

Condition	Intervention	Phase
Hypertension	Drug: LCZ696 Drug: Valsartan Drug: AHU377 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean sitting diastolic blood pressure change of LCZ696 compared to valsartan [ Time Frame: from baseline to week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MSSBP/MSDBP change of LCZ696 compared to placebo [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]

Enrollment:	1334
Study Start Date:	September 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LCZ696 (Dose 1)	Drug: LCZ696
Experimental: LCZ696 (Dose 2)	Drug: LCZ696
Experimental: LCZ696 (Dose 3)	Drug: LCZ696
Active Comparator: Valsartan (Dose 1)	Drug: Valsartan
Active Comparator: Valsartan (Dose 2)	Drug: Valsartan
Active Comparator: Valsartan (Dose 3)	Drug: Valsartan
Experimental: AHU377	Drug: AHU377
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Willing to sign informed consent
Male and females from 18 up to 75 years inclusive Mild-to-moderate uncomplicated essential hypertension Medication compliance ≥80 % compliance rate during the run-in period

Exclusion Criteria:

Severe hypertension (MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg)
Women of child-bearing potential (WOCBP) unless they are post-menopausal or use predefined acceptable methods of contraception
History of angioedema, drug-related or otherwise, as reported by the patient
Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549770

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936
Germany
Sites in Germany
Sites in Germany, Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ruilope LM, Dukat A, Böhm M, Lacourcière Y, Gong J, Lefkowitz MP. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet. 2010 Apr 10;375(9722):1255-66. Epub 2010 Mar 16.

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00549770 History of Changes
Other Study ID Numbers:	CLCZ696A2201
Study First Received:	October 5, 2007
Last Updated:	August 30, 2010
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Denmark: Danish Health Authorities; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: The Italian Medicines Agency; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: The Central Register of Clinical Trials; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Taiwan: Department of Health

Keywords provided by Novartis:

Hypertension, valsartan, LCZ696

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012