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

Novartis

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Valsartan; Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353508

CLCZ696B2223

Details and patient eligibility

About

Assess mechanism of action of LCZ696 related to sodium excretion.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups

LCZ696 to Valsartan - Heart Failure (HF) cohort

Experimental group

Description:

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.

Treatment:

Drug: LCZ696

Drug: Valsartan

Valsartan to LCZ696 - HF Cohort

Experimental group

Description:

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.

Treatment:

Drug: LCZ696

Drug: Valsartan

LCZ696 to Valsartan - Hypertension (HTN) cohort

Experimental group

Description:

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.

Treatment:

Drug: LCZ696

Drug: Valsartan

Valsartan to LCZ696 - HTN cohort

Experimental group

Description:

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.

Treatment:

Drug: LCZ696

Drug: Valsartan