Chronic coronary heart disease (stable angina)
Conditions
Interventions
Trade Name: Mildronate®
Pharmaceutical Form: Capsule*
INN or Proposed INN: meldonium
CAS Number: 76144815
Other descriptive name: mildronate
MET-88
dihydrate
3-(2,2,2-trimethylhydrazinium)-propionate dihidrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Capsule*
Route of admin
3-(2,2,2-trimethylhydrazinium)-propionate dihidrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Product Name: Mildronate
Pharmaceutical Form: Capsule*
INN
3-(2,2,2-trimethylhydrazinium)-propionate dihidrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
Joint Stock Company "Grindeks"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent; Age over 18 years; At least 3 months history prior to the study of stable effort angina II-III functional class according to classification of CCS verified either by: - previous myocardial infarction or - coronary angiography, or - precutaneous coronary angioplastics, or - caronary artery by-pass surgery, or - exercise test with typical findings of myocardial ischemia; Myocardial ischemia with ST-changes (horizontal or down sloping ST-depression >/=1mm) as the limiting factor of exercise in bicycle ergometry at least on visits 3 and 4; Willingness to comply with the standart antianginal therapy after visit 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) 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: Known intolerance of Mildronate preparation or its ingredients; Inability to perform bicycle ergometry test; Extreme obesity (body mass index >35kg/m2 Myocardial infarction, stroke or unstable angina within 3 months prior to the study and during the screening period; Coronary revascularization within 3 months prior to the study; Congestive heart failure class III-IV according to classification of NYHA; Hemodynamically significant valvular heart disease; Hemodynamically significant congenital heart disease; Acute myocarditis; Unischemic cardiomiopathia; Pericarditis; Cor pulmonale; Heart rate 100bpm at rest; Systolic blood preasure (sBP) 180mmHg or diastolic blood preasure (dBP) 110mmHg; Treatment with mildronate within 6 months prior to the study; Premenopausal females not using a medically accepted method of birth control; Pregnant or breastfeeding women;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asses the efficacy and safety of various doses of Mildronate in combination with standart therapy for the exercise tolerance of patients with stable angina pectoris.;Secondary Objective: To assess the efficacy of different various doses of Mildronate upon the symptoms of coronary heart disease, using the indices of physical exercise of patients with stable angina pectoris.;Primary end point(s): The change in exercise time in bicycle ergometry from baseline after 12 weeks treatment with Mildronate or placebo (at through drug concetrations) in comparison with the baseline data. | — |
Countries
Latvia
Outcome results
None listed