phase ii study of sta-2 in patients with chronic stable angina

Conditions: Chronic Stable Angina

Summary: the objectives of this study are to evaluate the efficacy, pharmacological activities and safety of sta-2 in the treatment of chronic stable angina.

the primary objective of this study was to evaluate the efficacy of sta-2 in the management of chronic stable angina. the secondary objectives of this study were to evaluate the safety and pharmacological activities of sta-2 in the management of chronic stable angina. this was a multi-center, double-blind, randomized, parallel-group, placebo-controlled study of sta-2 in the management of chronic stable angina. the study period for each patient was approximately 7 weeks, during which the patient undergone one-week screening and washout period, followed by 6 weeks of treatment. each patient was required to make a total of 5 visits. primary efficacy endpoint: change in total exercise time. after washout, patients who met the inclusion and exclusion criteria were randomly assigned either to the treatment or control group. the respective regimens were: treatment group: sta-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules ter in die (t.i.d.=three times daily) for 6 weeks, to be administered in a non-fasting state. control group: placebo 250 mg capsule, 2 capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.

Eligibility criteria:
inclusion criteria: 1. male or female aged \> 20; 2. patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction ≥ 3 months before screening; 3. patients who manifested positive ett (exercise tolerance testing) (defined as st-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening (day -7); 4. patients who manifested positive ett (exercise tolerance testing) (defined as st-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (day 0). ett performance between day -7 and day 0 were required not differ by \>20% in total exercise time; 5. female patient who was in the post-menopausal stage or of childbearing potential who: * used adequate contraception since last menstruation and no plan for conception during the study; * was non-lactating; * had negative pregnancy test (urine) within 14 days prior to the study; 6. able to provide written informed consent. exclusion criteria: 1. patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months; 2. patients with heart failure (new york heart association class iii or iv), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class i antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator; 3. patients with any ekg abnormalities preventing the interpretation of ischemia (complete left bundle branch block); 4. patients with chronic obstructive pulmonary disease (copd) requiring bronchodilators; 5. patients with hepatic failure (defined as aspartate transaminase (ast) and/or alanine transaminase (alt) \> 3x the upper limit of normal values), and/or renal failure (defined as serum creatinine \> 3 mg/dl); 6. patients with severe gastrointestinal illness as judged by the investigator; 7. patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, parkinsonism, stroke).

Keywords: green tea polyphenols chronic stable angina