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Completed

NCT Number: NCT01353508

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

Assess mechanism of action of LCZ696 related to sodium excretion.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Moscow, 117198, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCZ696

Drug

200 mg and 400 mg tablets

valsartan

Drug

160 mg tablets

Primary outcomes

  1. 24-hour Urinary Sodium Excretion

    Time frame: day 1

    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).

  2. Cumulative 7-day Urinary Sodium Excretion

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

    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).

Secondary outcomes

  1. 24-hour Diuresis

    Time frame: day 1

    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.

  2. 7-day Cumulative Diuresis

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

    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.

  3. Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours

    Time frame: day 1, day 6, day 7

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

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

    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

    MR-proANP was analyzed at a central laboratory.

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

    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

    BNP was analyzed at a central laboratory.

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

    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

    MR-proADM was analyzed at a central laboratory.

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

    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

    ProCNP was analyzed at a central laboratory.

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

    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

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

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

    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

    NT-proBNP was analyzed at a central laboratory.

  10. Percent Change From Baseline in Aldosterone Biomarker

    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

    Aldosterone was analyzed at a central laboratory.

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

    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

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

  12. Percent Change From Baseline in Blood Plasma Creatinine

    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

    Blood plasma creatinine was analyzed at a central laboratory.

  13. Glomerular Filtration Rate (GFR) Over Time

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

    GFR was used as a measure of renal function.

  14. Renal Blood Flow (RBF) Over Time

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

    RBF was used as a measure of renal function.

  15. Supine Systolic Blood Pressure

    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

    Systolic blood pressure measurements were taken.

  16. Supine Diastolic Blood Pressure

    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

    Diastolic blood pressure measurements were taken.

  17. Supine Pulse Rate

    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

    Pulse rate measurements were taken.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Controlled, Crossover Study to Evaluate the Sodium Excretion of LCZ696 in Patients With Stable Heart Failure, in Patients With Hypertension, and in Healthy Volunteers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 13, 2011
Registry last updated
Nov 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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