Phase IIb Study of STA-2 in Patients With Chronic Stable Angina

• Change in time to onset of angina from baseline to the final visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Changes in time to 1mm ST-segment depression during ETT from baseline to final visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Changes in time to maximum ST-segment depression during ETT from baseline to the final visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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.

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.

Treatment Group A:

150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)

Treatment Group B:

300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)

Treatment Group C:

450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)

Placebo Group:

Placebo capsule, 2 capsules t.i.d., after meal

• Placebo Comparator: Placebo group
  Intervention: Drug: green tea polyphenols (STA-2)
• Experimental: Treatment Group A
  150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
  Intervention: Drug: green tea polyphenols (STA-2)
• Experimental: Treatment Group B
  300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
  Intervention: Drug: green tea polyphenols (STA-2)
• Experimental: Treatment Group C
  450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
  Intervention: Drug: green tea polyphenols (STA-2)

Inclusion Criteria:

1. Male or female aged ≧ 20 years;
2. Patients who had more than 50% coronary stenosis documented by catheterization or ever received coronary intervention;
3. 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;
4. The difference in exercise duration between screening (Visit 1) and baseline (Visit 2) do not exceed 20% of the longer test;
5. Able to provide written informed consent.

Exclusion Criteria:

• 1) Patients with 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 need digoxin or digitalis; 3) Patients with any resting EKG abnormalities preventing the interpretation of ischemia as judged by the investigator; 4) Patients with COPD requiring bronchodilators; 5) Patients with impaired hepatic function (defined as AST and/or ALT > 3X the upper limit of normal values), and/or impaired renal function (defined as serum creatinine > 2 mg/dL); 6) Patients with documented evidence of gastroduodenal ulcer disease, gastrointestinal bleeding or other gastrointestinal disease within the preceding 3 months as judged by investigator; 7) Patients 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) Patient 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 patients of childbearing potential who:
• are lactating;
• have positive pregnancy test (urine) at V1; 10) Patient has received any investigational agent within 28 days prior to the first dose of investigational product; 11) Patients who have had administered STA-2 in prior clinical trial.