Clinical trial NCT01281306: An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension
Official title: A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg After 8 Week Treatment in Patients With Mild-to-moderate Systolic Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systolic Hypertension
Keywords: hypertension
blood pressure
LCZ696
dual-acting
neprilysin
nep inhibitor
vasopeptidase
angiotensin receptor
angiotensin receptor neprilysin inhibitor (ARNi)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 910
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: The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
* Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.

Exclusion Criteria:

* Severe hypertension
* History of angioedema, drug-related or otherwise, as reported by the patient.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
* History or evidence of a secondary form of hypertension.
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in Daytime maSBP and maDBP
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in Nighttime maSBP and maDBP
timeFrame: Baseline and 8 weeks
measure: Change From Baseline in Mean Sitting Pulse Pressure
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in Mean Ambulatory Pulse Pressure
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in maSBP and maDBP in Dippers
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in maSBP and maDBP in Non-dippers
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age
timeFrame: Baseline, 8 weeks
measure: Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response
timeFrame: 8 weeks
measure: Number of Participants With Adverse Events, Serious Adverse Events and Death
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Metairie
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Belzoni
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Henderson
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Shelby
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Erie
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Bryan
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Lanus
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Buenos aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Corrientes
country: Argentina
facility: Novartis Investigative Site
city: Mount Pearl
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Mirabel
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Csongrad
country: Hungary
facility: Novartis Investigative Site
city: Erd
country: Hungary
facility: Novartis Investigative Site
city: Miskolc
country: Hungary
facility: Novartis Investigative Site
city: Miskolc
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyháza
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
city: Vishakhapatnam
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Ludhiana
country: India
facility: Novartis Investigative Site
state: Punjab
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Bucheon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Uijeongbu-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Koyang
country: Korea, Republic of
facility: Novartis Investigative Site
state: Kyunggi
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 2
city: Oradea
country: Romania
facility: Novartis Investigative Site
state: Jud. Bihor
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Jud. Dolj
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Presov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Liptovsky Mikulas
country: Slovakia
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Partizanske
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Ruzomberok
country: Slovakia
facility: Novartis Investigative Site
city: Sala
country: Slovakia
facility: Novartis Investigative Site
city: Sered
country: Slovakia
facility: Novartis Investigative Site
city: Zvolen
country: Slovakia
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Tarragona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: