Phase IIb Study of STA-2 in Patients With Chronic Stable Angina
Condition: Chronic Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Intervention: green tea polyphenols (STA-2)
Intervention description: 2 capsules t.i.d., after meal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the dose-response of three different dose levels
      of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in
      patients with chronic stable angina.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged ≧ 20 years;

          2. Subjects weight > 50 kg

          3. subjects who had more than 50% coronary stenosis documented by catheterization or ever
             received coronary intervention;

          4. The two ETT results at screening (Visit 1) and baseline (Visit 2) show greater than or
             equal to 1 mm ST-segment depression within exercise duration;

          5. The difference in exercise duration between screening (Visit 1) and baseline (Visit 2)
             do not exceed 20% of the longer test;

          6. Able to provide written informed consent.

        Exclusion Criteria:

          1. Subjects with pacemaker rhythm, unstable angina or myocardial infarction within the
             preceding 3 months;

          2. Subjects with heart failure (New York Heart Association class III or IV), uncorrected
             valvular or congenital heart disease, subjects who need digoxin or digitalis;

          3. Subjects with any resting EKG abnormalities preventing the interpretation of ischemia
             as judged by the investigator;

          4. Subjects with COPD requiring bronchodilators;

          5. Subjects with impaired hepatic function (defined as AST or ALT > 2X the upper limit of
             normal values), or impaired renal function (defined as serum creatinine > 1.5 mg/dL),
             or diagnosis of any chronic renal/hepatic disease;

          6. Subjects with documented evidence of gastroduodenal ulcer disease, gastrointestinal
             bleeding or other gastrointestinal disease within the preceding 3 months as judged by
             investigator;

          7. Subjects who have a history or evidence of a medical condition that would expose them
             to an undue risk of a significant adverse event or interfere with safety assessments
             during the course of the trial, including but not limited to hepatic, renal,
             respiratory, cardiovascular, endocrine, immune, neurological, or hematological disease
             as determined by the clinical judgment of the investigator;

          8. Subject with any conditions that could interfere the performance of exercise tolerance
             test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stoke);

          9. Female subjects of childbearing potential who:

               -  are lactating;

               -  have positive pregnancy test (urine) at V1;

         10. Subject has received any investigational agent within 28 days prior to the first dose
             of investigational product;

         11. Subjects who have had administered STA-2 in prior clinical trial.