Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00549770
First received: October 5, 2007
Last updated: August 30, 2010
Last verified: August 2010
  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 2

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:


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 Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 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 April 17, 2014