Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
NCT ID: NCT01681576
Last Updated: 2015-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2012-08-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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LCZ696 followed by Valsartan
Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
Valsartan
Valsartan 320mg tablet once daily
LCZ696
LCZ696 400mg tablet once daily
Valsartan followed by LCZ696
Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
Valsartan
Valsartan 320mg tablet once daily
LCZ696
LCZ696 400mg tablet once daily
Interventions
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Valsartan
Valsartan 320mg tablet once daily
LCZ696
LCZ696 400mg tablet once daily
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Anaheim, California, United States
Novartis Investigative Site
Cypress, California, United States
Novartis Investigative Site
Glendale, California, United States
Novartis Investigative Site
Hong Kong, Shatin, NT, Hong Kong
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Koyang-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Taichung, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, ROC, Taiwan
Countries
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References
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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.
Other Identifiers
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CLCZ696A2222
Identifier Type: -
Identifier Source: org_study_id
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