Phase 2 N=32 Randomized Quadruple-blind Treatment

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01353508 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: 24-hour Urinary Sodium Excretion — 220.58; 198.73; 177.40; 146.18 mmol/24 hours

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LCZ696 (Drug); Valsartan (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY 24-hour Urinary Sodium Excretion	220.58; 198.73; 177.40; 146.18	—
PRIMARY Cumulative 7-day Urinary Sodium Excretion	1020.57; 1114.18; 906.81; 943.26	—
SECONDARY 24-hour Diuresis	3199.37; 2874.36; 3382.94; 2393.61	—
SECONDARY 7-day Cumulative Diuresis	12347.92; 13180.02; 16980.05; 15265.35	—
SECONDARY Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours	1851.79; 884.99; 1085.76; 557.53; 1467.67; 865.62	—
SECONDARY Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker	-7.04; 2.08; -10.11; -1.66; -17.39; -6.74	—
SECONDARY Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker	72.32; -8.93; -10.75; -5.94; 121.85; -0.83	—
SECONDARY Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker	8.04; -2.87; 21.22; -8.22; 20.18; -8.81	—
SECONDARY Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker	0.35; -1.01; 34.58; -6.02; 67.85; -16.19	—
SECONDARY Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker	36.39; 2.51; 108.87; 54.07; 32.44; 11.41	—
SECONDARY Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker	3.06; 6.87; 5.10; 8.32; 2.68; 13.21	—
SECONDARY Percent Change From Baseline in Aldosterone Biomarker	71.15; -14.63; 90.51; 72.92; 208.06; 8.36	—
SECONDARY Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)	-0.05; -1.40; 0.51; 0.08; -2.19; -2.46	—
SECONDARY Percent Change From Baseline in Blood Plasma Creatinine	-7.06; -3.55; -7.48; -0.91; -2.97; -0.07	—
SECONDARY Glomerular Filtration Rate (GFR) Over Time	76.4; 92.5; 87.6; 99.2; 115.7; 83.3	—
SECONDARY Renal Blood Flow (RBF) Over Time	398.1; 305.7; 774.7; 737.0; 361.3; 357.4	—
SECONDARY Supine Systolic Blood Pressure	114.8; 127.0; 136.1; 133.2; 122.8; 121.5	—
SECONDARY Supine Diastolic Blood Pressure	68.2; 74.1; 77.6; 74.9; 71.2; 75.5	—
SECONDARY Supine Pulse Rate	56.8; 61.7; 65.7; 65.5; 61.3; 60.7	—

Summary

Assess mechanism of action of LCZ696 related to sodium excretion.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01353508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.