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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 events

Cumulative 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

Page last updated: August 20, 2015

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