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

Phase 2CompletedNCT01353508

Novartis Pharmaceuticals32 enrolled

Overview

Assess mechanism of action of LCZ696 related to sodium excretion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

Interventions

LCZ696DRUG

200 mg and 400 mg tablets

ValsartanDRUG

160 mg tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Moscow, Russia

Outcomes

Primary Outcomes

24-hour Urinary Sodium Excretion

Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).

Time frame: day 1

Cumulative 7-day Urinary Sodium Excretion

Time frame: 7 day-cummulative (days 1 through 7)

Secondary Outcomes

24-hour Diuresis

Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.

Time frame: day 1

7-day Cumulative Diuresis

Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.

Time frame: 7-day cumulative (days 1 through 7)

Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours

cGMP was analyzed at a central laboratory. The measure type used for this OM was Geometric LSM.

Time frame: day 1, day 6, day 7

Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker

MR-proANP was analyzed at a central laboratory.

Time frame: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker

BNP was analyzed at a central laboratory.

Time frame: 0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7

Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker

MR-proADM was analyzed at a central laboratory.

Time frame: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7

Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker

ProCNP was analyzed at a central laboratory.

Time frame: 2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7

Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker

CT-proET-1 was analyzed at a central laboratory.

Time frame: 12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7

Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker

NT-proBNP was analyzed at a central laboratory.

Time frame: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7

Percent Change From Baseline in Aldosterone Biomarker

Aldosterone was analyzed at a central laboratory.

Time frame: 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7

Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)

Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium, potassium, albumin and calcium were measured.

Time frame: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7

Percent Change From Baseline in Blood Plasma Creatinine

Blood plasma creatinine was analyzed at a central laboratory.

Time frame: 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7

Glomerular Filtration Rate (GFR) Over Time

GFR was used as a measure of renal function.

Time frame: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7

Renal Blood Flow (RBF) Over Time

RBF was used as a measure of renal function.

Time frame: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7

Supine Systolic Blood Pressure

Systolic blood pressure measurements were taken.

Time frame: 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7

Supine Diastolic Blood Pressure

Diastolic blood pressure measurements were taken.

Time frame: 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7

Supine Pulse Rate

Pulse rate measurements were taken.

Time frame: 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7