Clinical trial NCT01615198: Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
Official title: A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 588
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients must give written informed consent before any assessment is performed
* Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and \< 180 mmHg
* Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance

Exclusion criteria:

* Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
* Patients with history or evidence of a secondary form of hypertension
* Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
* History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
* Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
* Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
* Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
* Patients with a clinically significant valvular heart disease at the time of screening
* Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
timeFrame: Baseline, 10 weeks
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, 4 weeks, 14 weeks
measure: Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
timeFrame: Baseline, 10 weeks
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, 10 weeks
measure: Change From Baseline in Mean Sitting Pulse Pressure
timeFrame: Baseline, 4 weeks, 10 weeks, 14 weeks
measure: Change From Baseline in Daytime and Nighttime maSBP/maDBP
timeFrame: Baseline, 10 weeks
measure: Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
timeFrame: Baseline, 10 weeks
measure: Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
timeFrame: Baseline, 10 weeks
measure: Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: 4 weeks, 10 weeks, 14 weeks
measure: Number of Participants Achieving Successful Response in msSBP and msDBP
timeFrame: 4 weeks,10 weeks, 14 weeks
measure: Number of Participants With Adverse Events, Serious Adverse Events and Death
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Novartis Investigative Site
state: Chongqing
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
state: Shatin, NT
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Toon-city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Chikushi-gun
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kyotanabe-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Toyonaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Fujimino
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hiki-Gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Koshigaya city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kunitachi
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Taito
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
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: Seongnam
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi
city: Jeonju-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeollabuk-do
city: Koyang
country: Korea, Republic of
facility: Novartis Investigative Site
state: Kyunggi
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daejeon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
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: 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: Seoul
country: Korea, Republic of
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: Valenzuela City
country: Philippines
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan, ROC
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: