Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Salt-sensitive Hypertension
Intervention: Valsartan (Drug); LCZ696 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and
blood pressure in salt-sensitive Asian hypertensive patients.
Clinical Details
Official title: A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: Cumulative Sodium excretion (natriuresis)Cumulative Sodium excretion (natriuresis)
Secondary outcome: Number of patients with adverse eventsCumulative Sodium excretion (natriuresis) Urine Volume (Diuresis) Mean seated blood pressure following 4 weeks of treatment Mean arterial pressure (MAP) after following 4 weeks of treatment Mean siting pulse pressure after 4 weeks of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Novartis Investigative Site, Seoul 120-752, Korea, Republic of
Novartis Investigative Site, Seoul 152-703, Korea, Republic of
Novartis Investigative Site, Singapore 119228, Singapore
Novartis Investigative Site, Singapore 169609, Singapore
Novartis Investigative Site, Taichung 40447, Taiwan
Novartis Investigative Site, Taipei 10002, Taiwan
Novartis Investigative Site, Taipei 114, Taiwan
Novartis Investigative Site, Anaheim, California 92801, United States
Novartis Investigative Site, Cypress, California 90630, United States
Novartis Investigative Site, Glendale, California 91206, United States
Novartis Investigative Site, Bucheon, Gyeonggi-do 424-717, Korea, Republic of
Novartis Investigative Site, Koyang-si, Gyeonggi-do 410-773, Korea, Republic of
Novartis Investigative Site, Seoul, Korea 110 744, Korea, Republic of
Novartis Investigative Site, Hong Kong, Shatin, NT, Hong Kong
Novartis Investigative Site, Taipei, Taiwan, ROC 112, Taiwan
Additional Information
Starting date: August 2012
Last updated: March 19, 2015
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