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Completed

NCT Number: NCT01681576

Assessment 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Hong Kong, Shatin, NT

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

Valsartan 320mg tablet once daily

LCZ696

Drug

LCZ696 400mg tablet once daily

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2012
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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