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Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LCZ696

Valsartan

AHU377

Placebo

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, valsartan, LCZ696

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or females from 18 up to and including 75 years
Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);

Exclusion Criteria:

Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
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 or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Active Comparator

Experimental

Placebo Comparator

Arm Label

LCZ696 100 mg

LCZ696 200 mg

LCZ696 400 mg

Valsartan 80 mg

Valsartan 160 mg

Valsartan 320 mg

AHU377 200 mg

Placebo

Arm Description

Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.

Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.

Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.

Secondary Outcome Measures

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Sitting BP measurements were performed at screening through the end of the study at every study visit.

Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP

Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8.

Change From Baseline in Daytime maDBP and maSBP

Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm.

Change From Baseline in Nighttime maDBP and maSBP

Percentage of Participants Who Achieved a Successful Response in msDBP

Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.

Percentage of Participants Who Achieved a Successful Response in msSBP

Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.

Percentage of Participants Who Achieved Successful Control in msDBP

Successful control in msDBP is defined as msDBP <90 mmHg.

Percentage of Participants Who Achieved Successful Control in msSBP

Successful control in msSBP is defined as <140 mmHg.

Full Information

NCT ID

NCT00549770

First Posted

October 5, 2007

Last Updated

August 11, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00549770

Brief Title

Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study was a dose-ranging efficiacy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Hypertension, valsartan, LCZ696

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1334 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCZ696 100 mg

Arm Type

Experimental

Arm Description

Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Arm Title

LCZ696 200 mg

Arm Type

Experimental

Arm Description

Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Arm Title

LCZ696 400 mg

Arm Type

Experimental

Arm Description

Arm Title

Valsartan 80 mg

Arm Type

Active Comparator

Arm Description

Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Arm Title

Valsartan 160 mg

Arm Type

Active Comparator

Arm Description

Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.

Arm Title

Valsartan 320 mg

Arm Type

Active Comparator

Arm Description

Arm Title

AHU377 200 mg

Arm Type

Experimental

Arm Description

Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Intervention Type

Drug

Intervention Name(s)

LCZ696

Intervention Type

Drug

Intervention Name(s)

Valsartan

Intervention Type

Drug

Intervention Name(s)

AHU377

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Description

Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.

Time Frame

baseline, week 8

Secondary Outcome Measure Information:

Title

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Description

Sitting BP measurements were performed at screening through the end of the study at every study visit.

Time Frame

baseline, week 8

Title

Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP

Description

Time Frame

baseline, 8 weeks

Title

Change From Baseline in Daytime maDBP and maSBP

Description

Time Frame

baseline, 8 weeks

Title

Change From Baseline in Nighttime maDBP and maSBP

Description

Time Frame

baseline, 8 weeks

Title

Percentage of Participants Who Achieved a Successful Response in msDBP

Description

Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.

Time Frame

8 weeks

Title

Percentage of Participants Who Achieved a Successful Response in msSBP

Description

Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.

Time Frame

8 weeks

Title

Percentage of Participants Who Achieved Successful Control in msDBP

Description

Successful control in msDBP is defined as msDBP <90 mmHg.

Time Frame

8 weeks

Title

Percentage of Participants Who Achieved Successful Control in msSBP

Description

Successful control in msSBP is defined as <140 mmHg.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or females from 18 up to and including 75 years Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs) Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2). Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3); Exclusion Criteria: Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg) 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 or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Chair

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-2041

Country

United States

Facility Name

Novartis Investigative Site

City

Muscle Shoals

State/Province

Alabama

ZIP/Postal Code

35662

Country

United States

Facility Name

Novartis Investigative Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Novartis Investigative Site

City

Buena Park

State/Province

California

ZIP/Postal Code

90620

Country

United States

Facility Name

Novartis Investigative Site

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

Facility Name

Novartis Investigative Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Novartis Investigative Site

City

Orangevale

State/Province

California

ZIP/Postal Code

95662

Country

United States

Facility Name

Novartis Investigative Site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Novartis Investigative Site

City

Stockton

State/Province

California

ZIP/Postal Code

95204

Country

United States

Facility Name

Novartis Investigative Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novartis Investigative Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Novartis Investigative Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Novartis Investigative Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

Novartis Investigative Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30904

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60610

Country

United States

Facility Name

Novartis Investigative Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61615

Country

United States

Facility Name

Novartis Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Novartis Investigative Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Novartis Investigative Site

City

Chelsea

State/Province

Michigan

ZIP/Postal Code

48118

Country

United States

Facility Name

Novartis Investigative Site

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

Novartis Investigative Site

City

Brooklyn Center

State/Province

Minnesota

ZIP/Postal Code

55430-2168

Country

United States

Facility Name

Novartis Investigative Site

City

St. Peters

State/Province

Missouri

ZIP/Postal Code

63376

Country

United States

Facility Name

Novartis Investigative Site

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08753

Country

United States

Facility Name

Novartis Investigative Site

City

Trenton

State/Province

New Jersey

ZIP/Postal Code

08629

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45224

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73132-4904

Country

United States

Facility Name

Novartis Investigative Site

City

Simpsonville

State/Province

South Carolina

ZIP/Postal Code

29681

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-3411

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77083

Country

United States

Facility Name

Novartis Investigative Site

City

Lake Jackson

State/Province

Texas

ZIP/Postal Code

77566

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25301

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1408INH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1416DRJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425AST

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000CXH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Corrientes

ZIP/Postal Code

W3400

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cambridge

State/Province

Ontario

ZIP/Postal Code

N1R 6V6

Country

Canada

Facility Name

Novartis Investigative Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

M4T 4J2

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Granby

State/Province

Quebec

ZIP/Postal Code

J2G 8Z9

Country

Canada

Facility Name

Novartis Investigative Site

City

Longueil

State/Province

Quebec

ZIP/Postal Code

J4N 1L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1J 2G2

Country

Canada

Facility Name

Novartis Investigative Site

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Novartis Investigative Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7H 5M3

Country

Canada

Facility Name

Novartis Investigative Site

City

Aalborg SV

ZIP/Postal Code

9200

Country

Denmark

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK-9000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Espergærde

ZIP/Postal Code

3060

Country

Denmark

Facility Name

Novartis Investigative Site

City

Greve

ZIP/Postal Code

2670

Country

Denmark

Facility Name

Novartis Investigative Site

City

Roslev

ZIP/Postal Code

7870

Country

Denmark

Facility Name

Novartis Investigative Site

City

Vaerloese

ZIP/Postal Code

DK-3500

Country

Denmark

Facility Name

Novartis Investigative Site

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00180

Country

Finland

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00350

Country

Finland

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00810

Country

Finland

Facility Name

Novartis Investigative Site

City

Kerava

ZIP/Postal Code

04200

Country

Finland

Facility Name

Novartis Investigative Site

City

Oulu

ZIP/Postal Code

90100

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Novartis Investigative Site

City

Bourges

ZIP/Postal Code

18000

Country

France

Facility Name

Novartis Investigative Site

City

La Chapelle sur Erdre

ZIP/Postal Code

44240

Country

France

Facility Name

Novartis Investigative Site

City

La Roche sur Yon

ZIP/Postal Code

85000

Country

France

Facility Name

Novartis Investigative Site

City

Le Pradet

ZIP/Postal Code

83220

Country

France

Facility Name

Novartis Investigative Site

City

Murs Erigné

ZIP/Postal Code

49610

Country

France

Facility Name

Novartis Investigative Site

City

Saint Avertin

ZIP/Postal Code

37550

Country

France

Facility Name

Novartis Investigative Site

City

Tours

ZIP/Postal Code

37000

Country

France

Facility Name

Novartis Investigative Site

City

Vihiers

ZIP/Postal Code

49310

Country

France

Facility Name

Novartis Investigative Site

City

Balve

ZIP/Postal Code

58802

Country

Germany

Facility Name

Novartis Investigative Site

City

Beckingen

ZIP/Postal Code

66701

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10719

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13053

Country

Germany

Facility Name

Novartis Investigative Site

City

Einbeck

ZIP/Postal Code

37574

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

ZIP/Postal Code

99084

Country

Germany

Facility Name

Novartis Investigative Site

City

Giengen

ZIP/Postal Code

89537

Country

Germany

Facility Name

Novartis Investigative Site

City

Hagen

ZIP/Postal Code

58095

Country

Germany

Facility Name

Novartis Investigative Site

City

Haigerloch

ZIP/Postal Code

72401

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22335

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34125

Country

Germany

Facility Name

Novartis Investigative Site

City

Krefeld

ZIP/Postal Code

47798

Country

Germany

Facility Name

Novartis Investigative Site

City

Mahlberg

ZIP/Postal Code

77972

Country

Germany

Facility Name

Novartis Investigative Site

City

Messkirch

ZIP/Postal Code

88605

Country

Germany

Facility Name

Novartis Investigative Site

City

Reinfeld

ZIP/Postal Code

23858

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57074

Country

Germany

Facility Name

Novartis Investigative Site

City

Wallerfing

ZIP/Postal Code

94574

Country

Germany

Facility Name

Novartis Investigative Site

City

Warendorf

ZIP/Postal Code

48231

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Novartis Investigative Site

City

Esztergom

ZIP/Postal Code

2500

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyháza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Caserta

State/Province

ZIP/Postal Code

81100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cona

State/Province

ZIP/Postal Code

44100

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Pozzilli

State/Province

ZIP/Postal Code

86077

Country

Italy

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Vimercate

State/Province

ZIP/Postal Code

20059

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Casorate Primo

State/Province

ZIP/Postal Code

27022

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Stradella

State/Province

ZIP/Postal Code

27049

Country

Italy

Facility Name

Novartis Investigative Site

City

Mercato San Severino

State/Province

ZIP/Postal Code

84085

Country

Italy

Facility Name

Novartis Investigative Site

City

Sassari

State/Province

ZIP/Postal Code

07100

Country

Italy

Facility Name

Novartis Investigative Site

City

San Daniele Del Friuli

State/Province

ZIP/Postal Code

33038

Country

Italy

Facility Name

Novartis Investigative Site

City

Vibo Valentia

State/Province

ZIP/Postal Code

89900

Country

Italy

Facility Name

Novartis Investigative Site

City

Daugavplis

ZIP/Postal Code

LV-5417

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kuldiga

ZIP/Postal Code

LV-3300

Country

Latvia

Facility Name

Novartis Investigative Site

City

Ogre

ZIP/Postal Code

5001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1012

Country

Latvia

Facility Name

Novartis Investigative Site

City

Alytus

ZIP/Postal Code

LT-62381

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

3007

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

LT-47144

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

LT-49387

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Den Bosch

ZIP/Postal Code

5216 GC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Deurne

ZIP/Postal Code

5751 XJ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Ermelo

ZIP/Postal Code

3851 EX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hoogwoud

ZIP/Postal Code

1718 BG

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Losser

ZIP/Postal Code

7581 BV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Oude Pekela

ZIP/Postal Code

9665 AR

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Poortvliet

ZIP/Postal Code

4693 BT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Wamel

ZIP/Postal Code

6659 BX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Olawa

ZIP/Postal Code

55-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Ostrow Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Novartis Investigative Site

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

101990

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

105077

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

S.-Petersburg

ZIP/Postal Code

191187

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

S.-Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sankt-Peterburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Banska Bystrica

State/Province

Slovak Republic

ZIP/Postal Code

974 05

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

813 69

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

State/Province

Slovak Republic

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

State/Province

Slovak Republic

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Dunajska Streda

ZIP/Postal Code

929 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

012 07

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

State/Province

Baleares

ZIP/Postal Code

07007

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Cataluña

ZIP/Postal Code

08914

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08025

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08905

Country

Spain

Facility Name

Novartis Investigative Site

City

Tarrega

State/Province

Cataluña

ZIP/Postal Code

25300

Country

Spain

Facility Name

Novartis Investigative Site

City

Vic

State/Province

Cataluña

ZIP/Postal Code

08500

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03004

Country

Spain

Facility Name

Novartis Investigative Site

City

Benidorm

State/Province

Comunidad Valenciana

ZIP/Postal Code

03550

Country

Spain

Facility Name

Novartis Investigative Site

City

Quart de Poblet

State/Province

Comunidad Valenciana

ZIP/Postal Code

46930

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

460009

Country

Spain

Facility Name

Novartis Investigative Site

City

Begonte

State/Province

Galicia

ZIP/Postal Code

27373

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08820

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llbregat

ZIP/Postal Code

08902

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Petrel

ZIP/Postal Code

03610

Country

Spain

Facility Name

Novartis Investigative Site

City

Riudecols

ZIP/Postal Code

43390

Country

Spain

Facility Name

Novartis Investigative Site

City

Arvidsjaur

ZIP/Postal Code

933 83

Country

Sweden

Facility Name

Novartis Investigative Site

City

Boden

ZIP/Postal Code

SE 961 31

Country

Sweden

Facility Name

Novartis Investigative Site

City

Karlstad

ZIP/Postal Code

652 25

Country

Sweden

Facility Name

Novartis Investigative Site

City

Kil

ZIP/Postal Code

665 30

Country

Sweden

Facility Name

Novartis Investigative Site

City

Kristianstad

ZIP/Postal Code

291 54

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

SE-222 21

Country

Sweden

Facility Name

Novartis Investigative Site

City

Skellefteå

ZIP/Postal Code

SE 931 32

Country

Sweden

Facility Name

Novartis Investigative Site

City

Taichung

State/Province

Taiwan ROC

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Tainan 704

State/Province

Taiwan ROC

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung County

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

26280447

Citation

Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.

Results Reference

derived

PubMed Identifier

20236700

Citation

Ruilope LM, Dukat A, Bohm M, Lacourciere 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. doi: 10.1016/S0140-6736(09)61966-8. Epub 2010 Mar 16.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

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Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial