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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 5, 2007

Last Updated Date

August 30, 2010

Start Date ^ICMJE

September 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Mean sitting diastolic blood pressure lowering from baseline to week 8 of LCZ696 compared to valsartan

Change History

Complete list of historical versions of study NCT00549770 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

MSSBP/MSDBP lowering from baseline to week 8 of LCZ696 compared to placebo

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: LCZ696
Drug: Valsartan
Drug: AHU377
Drug: Placebo

Study Arm (s)

Experimental: LCZ696 (Dose 1)
Intervention: Drug: LCZ696
Experimental: LCZ696 (Dose 2)
Intervention: Drug: LCZ696
Experimental: LCZ696 (Dose 3)
Intervention: Drug: LCZ696
Active Comparator: Valsartan (Dose 1)
Intervention: Drug: Valsartan
Active Comparator: Valsartan (Dose 2)
Intervention: Drug: Valsartan
Active Comparator: Valsartan (Dose 3)
Intervention: Drug: Valsartan
Experimental: AHU377
Intervention: Drug: AHU377
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1334

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany

Administrative Information

NCT Number ^ICMJE

NCT00549770

Other Study ID Numbers ^ICMJE

CLCZ696A2201

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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