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Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers

NCT ID: NCT01353508

Last Updated: 2015-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-08-31

Brief Summary

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Assess mechanism of action of LCZ696 related to sodium excretion.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LCZ696 to Valsartan - Heart Failure (HF) cohort

Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

200 mg and 400 mg tablets

Valsartan

Intervention Type DRUG

160 mg tablets

Valsartan to LCZ696 - HF Cohort

Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

200 mg and 400 mg tablets

Valsartan

Intervention Type DRUG

160 mg tablets

LCZ696 to Valsartan - Hypertension (HTN) cohort

Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

200 mg and 400 mg tablets

Valsartan

Intervention Type DRUG

160 mg tablets

Valsartan to LCZ696 - HTN cohort

Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

200 mg and 400 mg tablets

Valsartan

Intervention Type DRUG

160 mg tablets

Interventions

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LCZ696

200 mg and 400 mg tablets

Intervention Type DRUG

Valsartan

160 mg tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with heart failure: documented NYHA class II-III heart failure
* Patients with hypertension: stable hypertensive medication for the preceding 2 months

Exclusion Criteria

* Women of childbearing potential
* History of recent myocardial infarction
* History of dialysis or renal transplant
* Patients with type 1 diabetes mellitus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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CLCZ696B2223

Identifier Type: -

Identifier Source: org_study_id