Clinical trial NCT01681576: Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
Official title: A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Salt-sensitive Hypertension
Keywords: hypertension, salt sensitivity, valsartan, LCZ696
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-09-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.


Eligibility criteria: Key Inclusion Criteria:

* Written informed consent must be obtained before any study assessment is performed.
* Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
* Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.

Key Exclusion Criteria:

* Women of child-bearing potential.
* History of angioedema, drug-related or otherwise
* History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
* Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
* History or evidence of a secondary form of hypertension,
* Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
* History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
* Current or history of hypertensive retinopathy.
* Previous or current diagnosis of heart failure (NYHA Class II-IV).
* Clinically significant valvular heart disease at screening.

Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Cumulative Sodium Excretion (Natriuresis) at Day 1
timeFrame: 0-6 and 0-24 hours on Day 1
Secondary outcomes:
measure: Cumulative Sodium Excretion (Natriuresis) at Day 28
timeFrame: 0-6 and 0-24 hours on Day 28
measure: Urine Volume (Diuresis) Over Time
timeFrame: Day -1, Day 1 & Day 28
measure: Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time
timeFrame: Day-1, Day 14 and Day 28
measure: Mean Sitting Pulse Pressure (PP) Over Time
timeFrame: Day-1, Day 14 and Day 28
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novartis Investigative Site
state: California
city: Cypress
country: United States
facility: Novartis Investigative Site
state: California
city: Glendale
country: United States
facility: Novartis Investigative Site
state: California
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
state: Shatin, NT
city: Bucheon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Koyang-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
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan, ROC
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Wang TD, Tan RS, Lee HY, Ihm SH, Rhee MY, Tomlinson B, Pal P, Yang F, Hirschhorn E, Prescott MF, Hinder M, Langenickel TH. Effects of Sacubitril/Valsartan (LCZ696) on Natriuresis, Diuresis, Blood Pressures, and NT-proBNP in Salt-Sensitive Hypertension. Hypertension. 2017 Jan;69(1):32-41. doi: 10.1161/HYPERTENSIONAHA.116.08484. Epub 2016 Nov 14.