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Evaluation of the effects of 4 oral dosages of S 44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.

Evaluation of the effects of 4 oral dosages of S 44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011558-16-PT
Enrollment
125
Registered
2010-01-06
Start date
2010-03-16
Completion date
Unknown
Last updated
2013-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure and left ventricular dysfunction MedDRA version: 12.0 Level: LLT Classification code 10007558 Term: Cardiac failure chronic MedDRA version: 12.0 Level: LLT Classification code 10049694 Term: Left ventricular dysfunction

Interventions

Product Name: S44121 Product Code: S44121 Pharmaceutical Form: Granules for oral suspension Current Sponsor code: S44121 Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female patients superior or equal to 18 years and less or equal to 75 years. - Symptomatic chronic heart failure for at least 6 months before selection. - NYHA functional class II or III. - Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF. - Left ventricular systolic dysfunction as evidenced by a LVEF less or equal to 35 % as measured within 6 months before selection. - Beta-blocker treatment for at least 3 months before selection. - ACE inhibitor and/or an ARB treatment for at least 3 months before selection. - NT-proBNP plasma concentration superior or equal to 400 pg/mL or BNP plasma concentration superior or equal to 100 pg/mL. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Unstable condition within the previous 4 weeks before selection. - Recent (less than 3 months before selection) myocardial infarction, unstable angina or coronary revascularisation. - History of stroke or cerebral transient ischemic attack within the previous 3 months before selection. - Severe aortic or mitral stenosis, severe aortic regurgitation, or severe mitral regurgitation. - Congenital heart disease. - Hypertrophic obstructive cardiomyopathy. - Pericardial disease. - Atrio-ventricular block of second or third degree. - Corrected QT interval duration (Bazett’s formula) > 450 ms. - Family history of long QT syndrome or congenital long QT syndrome. - Serum creatinine > 200 micromoles/L (> 2.26 mg/dL). - ALAT or ASAT > 3 times the upper limit of normal values. - Serum total calcium 2.6 mmol/L. - Blood hemoglobin lower than 110 g/L (in males) or lower than 100 g/L (in females).

Design outcomes

Primary

MeasureTime frame
Main Objective: - Evaluation of the effects on cardiac function and NT-proBNP. ;Secondary Objective: - Evaluation of the safety profile.;Primary end point(s): - Echocardiographic parameters. - NT-proBNP plasma concentrations.—

Countries

Germany, Italy, Portugal, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026