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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353508
• Other study ID #: CLCZ696B2223
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2011
• Last updated: October 20, 2015
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

Assess mechanism of action of LCZ696 related to sodium excretion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• LCZ696
200 mg and 400 mg tablets
• Valsartan
160 mg tablets

Locations

Country	Name	City	State
Russian Federation	Novartis Investigative Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	day 1	No
Primary	Cumulative 7-day 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).	7 day-cummulative (days 1 through 7)	No
Secondary	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.	day 1	No
Secondary	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.	7-day cumulative (days 1 through 7)	No
Secondary	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.	day 1, day 6, day 7	No
Secondary	Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker	MR-proANP was analyzed at a central laboratory.	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	No
Secondary	Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker	BNP was analyzed at a central laboratory.	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	No
Secondary	Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker	MR-proADM was analyzed at a central laboratory.	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	No
Secondary	Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker	ProCNP was analyzed at a central laboratory.	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	No
Secondary	Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker	CT-proET-1 was analyzed at a central laboratory.	12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7	No
Secondary	Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker	NT-proBNP was analyzed at a central laboratory.	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	No
Secondary	Percent Change From Baseline in Aldosterone Biomarker	Aldosterone was analyzed at a central laboratory.	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	No
Secondary	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.	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	No
Secondary	Percent Change From Baseline in Blood Plasma Creatinine	Blood plasma creatinine was analyzed at a central laboratory.	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	No
Secondary	Glomerular Filtration Rate (GFR) Over Time	GFR was used as a measure of renal function.	0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7	No
Secondary	Renal Blood Flow (RBF) Over Time	RBF was used as a measure of renal function.	0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7	No
Secondary	Supine Systolic Blood Pressure	Systolic blood pressure measurements were taken.	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	No
Secondary	Supine Diastolic Blood Pressure	Diastolic blood pressure measurements were taken.	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	No
Secondary	Supine Pulse Rate	Pulse rate measurements were taken.	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	No