Mildronate-efficacy and safety in treatment for chronic coronary heart disease (stable angina) - II - MILSS II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001611-58-LT

Enrollment

300

Registered

2004-12-21

Start date

2005-05-10

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Chronic coronary heart disease (stable angina)

Interventions

Trade Name: Mildronate Product Name: Mildronate Product Code: no Pharmaceutical Form: Capsule* INN or Proposed INN: 3-(2,2,2-Trimethylhydrazinium)propionate CAS Number: 76 144-81-5 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written informed consent. Age over 18 years. At least 3 months prior to the study history of stable effort angina II-III functional class according to classification of CCS. Myocardial ischaemia with typical ST - changes (horizontal or down sloping ST-depresion = 1 mm) as the limiting factor of exercise in bicycle ergometry at least on visits 3 and 4. Willingness to comply with the standard 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) 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: Known intolerance of mildronate or its ingredients. Inability to perform bicycle ergometry test. Myocardial infarction, stroke or unstable angina within 3 months prior to the study and during the screening period. Hemodynamically significant valvular heart disease. Sustained ventricular tachycardia, supraventricular tachycardia, ventricular flutter or fibrillation within 3 months prior to the study. Over 20 % difference in the exercise time between the last two exercise tests of the run-in period. Exercise time less than 3 or more than 13 minutes in bicycle ergometry at visit 4. Serious changes of ECG, making impossible correct interpretation of bicycle ergometry results. Any medical condition making the patient unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
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 efficacy of mildronate on the symptoms of CHD, using the indices of exercise capacity for patients with stable angina;Primary end point(s): The change in exercise time in bicycle ergometry from baseline after 12 months treatment.	—

Measure

Time frame

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 efficacy of mildronate on the symptoms of CHD, using the indices of exercise capacity for patients with stable angina;Primary end point(s): The change in exercise time in bicycle ergometry from baseline after 12 months treatment.

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Countries

Latvia, Lithuania

Outcome results

None listed

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