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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681576
First Posted: September 10, 2012
Last Update Posted: November 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.

Condition Intervention Phase
Salt-sensitive Hypertension Drug: Valsartan Drug: LCZ696 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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

  • 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.

  • 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


Enrollment: 72
Study Start Date: August 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681576


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01681576     History of Changes
Other Study ID Numbers: CLCZ696A2222
First Submitted: August 30, 2012
First Posted: September 10, 2012
Results First Submitted: July 10, 2015
Results First Posted: October 9, 2015
Last Update Posted: November 10, 2015
Last Verified: October 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
hypertension, salt sensitivity, valsartan, LCZ696

Additional relevant MeSH terms:
Hypertension
Hypersensitivity
Vascular Diseases
Cardiovascular Diseases
Immune System Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action


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