Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

Hypertension Clinical Trial

Official title:

A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876368
• Other study ID #: CLCZ696A2318
• Secondary ID: 2013-001783-36
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2013
• Last updated: November 3, 2015
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChina: Food and Drug AdministrationDominican Republic: Consejo Nacional de Bioetica en SaludJapan: Pharmaceuticals and Medical Devices AgencyGuatemala: Ministry of Public Health and Social AssistancePeru: Digemid: Retiran del mercado fármaco CordaptivePhilippines: Bureau of Food and DrugsRussia: Ministry of Health of the Russian FederationSingapore: Health Products Regulation Group (HPRG)Spain: Agencia Española de Medicamentos y Productos SanitariosTaiwan: Department of HealthVenezuela: INH/INHRR, Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy

• treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP = 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch

• untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP = 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP = 145 mmHg and < 180 mmHg after 4 weeks run-in epoch

• patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Exclusion Criteria:

• Malignant or severe hypertension (grade 3 of WHO classification; msDBP =110 mmHg and/or msSBP = 180 mmHg)

• History of angioedema, drug-related or otherwise

• 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 (PKD), drug-induced hypertension

• Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

Study Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• LCZ696

• Olmesartan

• Placebo of LCZ696

• Placebo of Olmesartan

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Capital Federal
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Posadas	Misiones
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City	Manila
Puerto Rico	Novartis Investigative Site	Manati
Puerto Rico	Novartis Investigative Site	Ponce
Puerto Rico	Novartis Investigative Site	Ponce
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	St.- Petersburg
Spain	Novartis Investigative Site	Alzira	Comunidad Valenciana
Spain	Novartis Investigative Site	Centelles	Cataluña
Spain	Novartis Investigative Site	Hostalets de Balenya	Cataluña
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Belzoni	Mississippi
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Conyers	Georgia
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Edina	Minnesota
United States	Novartis Investigative Site	Fair Oaks	California
United States	Novartis Investigative Site	Hawaiian Gardens	California
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Orangevale	California
United States	Novartis Investigative Site	Oregon City	Oregon
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Varnville	South Carolina
United States	Novartis Investigative Site	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Guatemala,  Philippines,  Puerto Rico,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)	Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.	baseline, 8 weeks	No
Secondary	Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)	Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.	baseline, 8 weeks	No
Secondary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean	baseline, 8 weeks	No
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean	baseline, 8 weeks	No
Secondary	Change From Baseline in Office Pulse Pressure	Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.	baseline, 8 weeks	No
Secondary	Number of Patients Achieving Successful Overall Blood Pressure Control	Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg	8 weeks	No
Secondary	Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control	Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg	8 weeks	No
Secondary	Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control	Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg	8 weeks	No
Secondary	Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response	Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction = 20 mmHg from baseline.	baseline, 8 weeks	No
Secondary	Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response	Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction =10 mmHg from baseline.	baseline, 8 weeks	No
Secondary	Number of Patients With Total Adverse Events, Serious Adverse Events and Death	Number of patients with total adverse events, serious adverse events and death were reported.	8 weeks	Yes