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

NCT01681576 | Completed Phase 2 Results

• 1 other identifier: CLCZ696A2222
• Study Type: interventional
• Target: 72
• Locations: 5 countries
• Sites: 15

Brief Summary

This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.

Conditions

Salt-sensitive Hypertension

Keywords

hypertension, salt sensitivity, valsartan, LCZ696

Outcome Measures

Primary Outcomes (1)

• Cumulative Sodium Excretion (Natriuresis) at 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

  0-6 and 0-24 hours on Day 1

Secondary Outcomes (4)

• Cumulative Sodium Excretion (Natriuresis) at Day 28

  0-6 and 0-24 hours on Day 28

• Urine Volume (Diuresis) Over Time

  Day -1, Day 1 & Day 28

• Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time

  Day-1, Day 14 and Day 28

• Mean Sitting Pulse Pressure (PP) Over Time

  Day-1, Day 14 and Day 28

Study Arms (2)

LCZ696 followed by Valsartan

EXPERIMENTAL

Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks

Drug: Valsartan; Drug: LCZ696

Valsartan followed by LCZ696

EXPERIMENTAL

Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks

Drug: Valsartan; Drug: LCZ696

Interventions

Valsartan DRUG

Valsartan 320mg tablet once daily

LCZ696 followed by Valsartan; Valsartan followed by LCZ696

LCZ696 DRUG

LCZ696 400mg tablet once daily

LCZ696 followed by Valsartan; Valsartan followed by LCZ696

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Novartis Investigative Site

Anaheim, California, 92801, United States

Location

Novartis Investigative Site

Cypress, California, 90630, United States

Location

Novartis Investigative Site

Glendale, California, 91206, United States

Location

Novartis Investigative Site

Hong Kong, Shatin, NT, Hong Kong

Location

Novartis Investigative Site

Singapore, Singapore, 119228, Singapore

Location

Novartis Investigative Site

Singapore, Singapore, 169609, Singapore

Location

Novartis Investigative Site

Bucheon-si, Gyeonggi-do, 424-717, South Korea

Location

Novartis Investigative Site

Koyang-si, Gyeonggi-do, 410-773, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

Location

Novartis Investigative Site

Seoul, 120-752, South Korea

Location

Novartis Investigative Site

Seoul, 152-703, South Korea

Location

Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 114, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, ROC, 112, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 27849566 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 10, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 10, 2015
• Results First Posted: October 9, 2015

Record last verified: 2015-10

Locations

SG (2); US (3); HK (1); KR (5); TW (4)