Mildronate-efficacy and safety in treatment for chronic coronary heart Disease (stable angina) II - MILSS II
- Conditions
- Chronic coronary heart disease (stable angina)
- Registration Number
- EUCTR2004-001611-58-LV
- Lead Sponsor
- JSC Grindeks
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Written informed consent. Age over 18 years. At least 3 months history of stable effort angina relieved by rest or sublingual nitroglycerin. Coronary heart disease with severity of CCS class II-III. Myocardial ischaemia with typical ST - changes as the limiting factor of exercise in bicycle ergometry.
Are the trial subjects under 18?
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
Known intolerance of mildronate or its ingredients. Inability to perform bicycle ergometry test. Myocardial infarction, stroke or unstable angina within 3 months before randomisation. Hemodynamically significant valvular heart disease. Sustained ventricular tachycardia, supraventricular tachycardia, ventricular flutter or fibrillation within 3 months prior the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to assess the efficacy and safety of the treatment with mildronate in combination with standard therapy for the exercise tolerance of patients with stable angina pectoris;Secondary Objective: to assess the change in the exercise time in bicycle ergometry from baseline after treatment with mildronate or placebo (at through drug concentrations);Primary end point(s): The change in exercise ime in bicycle ergometry from baseline after 12months treatment.
- Secondary Outcome Measures
Name Time Method