Clinical trial NCT01876368: Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension,
LCZ696,
olmesartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-06-12
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)
timeFrame: baseline, 8 weeks
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: baseline, 8 weeks
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: baseline, 8 weeks
measure: Change From Baseline in Office Pulse Pressure
timeFrame: baseline, 8 weeks
measure: Number of Patients Achieving Successful Overall Blood Pressure Control
timeFrame: 8 weeks
measure: Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control
timeFrame: 8 weeks
measure: Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control
timeFrame: 8 weeks
measure: Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response
timeFrame: baseline, 8 weeks
measure: Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response
timeFrame: baseline, 8 weeks
measure: Number of Patients With Total Adverse Events, Serious Adverse Events and Death
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Fair Oaks
country: United States
facility: Novartis Investigative Site
state: California
city: Hawaiian Gardens
country: United States
facility: Novartis Investigative Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Orangevale
country: United States
facility: Novartis Investigative Site
state: California
city: Westlake Village
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Conyers
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Edina
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Belzoni
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oregon City
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Varnville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: Posadas
country: Argentina
facility: Novartis Investigative Site
state: Misiones
city: Buenos aires
country: Argentina
facility: Novartis Investigative Site
city: Corrientes
country: Argentina
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
state: Manila
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Manati
country: Puerto Rico
facility: Novartis Investigative Site
city: Ponce
country: Puerto Rico
facility: Novartis Investigative Site
city: Ponce
country: Puerto Rico
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: St.- Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Hostalets de Balenya
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: