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

Sinphar Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Chronic Stable Angina

Treatments: Drug: green tea polyphenols (STA-2)

Study type: Interventional

Funder types: Other

Identifiers

NCT01239511

MCCD09004A

Details and patient eligibility

About

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.

Full description

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

Enrollment: 186 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 4 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

placebo capsule 2# t.i.d./day

Treatment:

Drug: green tea polyphenols (STA-2)

Treatment Group A

Experimental group

Description:

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

Treatment:

Drug: green tea polyphenols (STA-2)

Treatment Group B

Experimental group

Description:

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

Treatment:

Drug: green tea polyphenols (STA-2)

Treatment Group C

Experimental group

Description:

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

Treatment:

Drug: green tea polyphenols (STA-2)