Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension

Salt-sensitive Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681576
• Other study ID #: CLCZ696A2222
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2012
• Last updated: October 12, 2015
• Start date: August 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug AdministrationTaiwan: Department of HealthSingapore: Health Sciences AuthorityHong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hypertension
• Salt-sensitive Hypertension

Intervention

Drug:
• Valsartan
Valsartan 320mg tablet once daily
• LCZ696
LCZ696 400mg tablet once daily

Locations

Country	Name	City	State
Hong Kong	Novartis Investigative Site	Hong Kong	Shatin, NT
Korea, Republic of	Novartis Investigative Site	Bucheon	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Koyang-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei	Taiwan, ROC
United States	Novartis Investigative Site	Anaheim	California
United States	Novartis Investigative Site	Cypress	California
United States	Novartis Investigative Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Hong Kong,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Sodium Excretion (Natriuresis) at Day 1	Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1	0-6 and 0-24 hours on Day 1	No
Secondary	Cumulative Sodium Excretion (Natriuresis) at Day 28	Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28	0-6 and 0-24 hours on Day 28	No
Secondary	Urine Volume (Diuresis) Over Time	Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28	Day -1, Day 1 & Day 28	No
Secondary	Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time	Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.	Day-1, Day 14 and Day 28	No
Secondary	Mean Sitting Pulse Pressure (PP) Over Time	Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements	Day-1, Day 14 and Day 28	No