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

October 12, 2015 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Shatin, NT
      • Hong Kong, Shatin, NT, Hong Kong
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 152-703
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 424-717
        • Novartis Investigative Site
      • Koyang-si, Gyeonggi-do, Korea, Republic of, 410-773
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 110 744
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119228
        • Novartis Investigative Site
      • Singapore, Singapore, 169609
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
    • Taiwan, ROC
      • Taipei, Taiwan, ROC, Taiwan, 112
        • Novartis Investigative Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novartis Investigative Site
      • Cypress, California, United States, 90630
        • Novartis Investigative Site
      • Glendale, California, United States, 91206
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LCZ696 followed by Valsartan
Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
Drug: Valsartan
Valsartan 320mg tablet once daily
Drug: LCZ696
LCZ696 400mg tablet once daily
Experimental: Valsartan followed by LCZ696
Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
Drug: Valsartan
Valsartan 320mg tablet once daily
Drug: LCZ696
LCZ696 400mg tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Sodium Excretion (Natriuresis) at Day 1
Time Frame: 0-6 and 0-24 hours on 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Sodium Excretion (Natriuresis) at Day 28
Time Frame: 0-6 and 0-24 hours on 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
Urine Volume (Diuresis) Over Time
Time Frame: Day -1, Day 1 & Day 28
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
Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time
Time Frame: Day-1, Day 14 and Day 28
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
Mean Sitting Pulse Pressure (PP) Over Time
Time Frame: Day-1, Day 14 and Day 28
Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements
Day-1, Day 14 and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCZ696A2222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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