EUCTR2013-003000-39-EE
Active, not recruiting
Not Applicable
Evaluation of the pharmacodynamics, pharmacokinetics andsafety of repeated escalating oral doses of S 38844 versus placeboin patients with chronic heart failure and left ventricular systolicdysfunctionA phase II, randomised, double-blind, parallel-group, placebocontrolled, international multicentre study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut de Recherches Internationales Servier
- Enrollment
- 125
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Documented sinus rhythm and mean HR \= 75 bpm measured on two consecutive resting 12\-leads ECGs recordings one minute registration \- performed at least 5 minutes apart (supine position for at least 10 minutes rest). If one of the two HR measurements is 73 or 74 bpm at the inclusion visit, the patient can be included provided that the mean of both HR measurements at the visit is \= 75 bpm,
- •\- LVEF \= 35% as measured and documented within the previous 6 months (in stable clinical condition). For patient without known diagnosis of LVEF \= 35%, a LVEF will be scheduled before inclusion visit,
- •\- Compliant to study treatment during run\-in period (70\-130%),
- •\- Symptomatic CHF of New York Heart Association (NYHA) class II, III or IV for at least 3 months prior to selection,
- •\- In stable clinical condition with regards to CHF symptoms for at least 4 weeks prior to selection,
- •\- With optimal and unchanged CHF medications or dosages, for at least 4 weeks prior to selection.
- •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 75
Exclusion Criteria
- •\- LVEF of 35% or higher on a recently performed measurement (less than 6 months),
- •\- Serum haemoglobin \< 110 g/L,
- •\- ALT or AST \> 3 times the upper limit of normal values,
- •\- Significant change in cardiovascular condition, since the informed consent signature, change in heart failure background therapy or dosage, or use of intravenous inotropic therapies,
- •\- Recent (less than 3 months) myocardial infarction or coronary revascularization,
- •\- Scheduled coronary revascularization,
- •\- Severe aortic or mitral stenosis, or severe aortic regurgitation, or severe primary mitral regurgitation,
- •\- Scheduled surgery for valvular heart disease,
- •\- Cardiac Resynchronisation Therapy (CRT),
- •\- Pacemaker carrier,
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).EUCTR2013-003000-39-HUInstitut de Recherches Internationales Servier200
Active, not recruiting
Not Applicable
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).Patients with chronic heart failure and left ventricular systolicdysfunctionMedDRA version: 17.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2013-003000-39-BEInstitut de Recherches Internationales Servier125
Active, not recruiting
Not Applicable
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).Patients with chronic heart failure and left ventricular systolicdysfunctionMedDRA version: 17.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2013-003000-39-SKInstitut de Recherches Internationales Servier200
Active, not recruiting
Not Applicable
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).Patients with chronic heart failure and left ventricular systolicdysfunctionMedDRA version: 17.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2013-003000-39-LTInstitut de Recherches Internationales Servier125
Active, not recruiting
Not Applicable
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).Patients with chronic heart failure and left ventricular systolicdysfunctionMedDRA version: 17.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2013-003000-39-LVInstitut de Recherches Internationales Servier200