Phase IIb Study of STA-2 in Patients With Chronic Stable Angina
CompletedPhase 2NCT01239511
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Dose-Response and Safety of STA-2 in Patients With Chronic Stable Angina
- Conditions
- Interventions
- Drug: green tea polyphenols (STA-2)
- Sponsor
- Sinphar Pharmaceutical Co., Ltd
- Start date
- 2010-11
- Primary completion
- 2012-04
- Sex
- All
- Age range
- from 20 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Taiwan
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01239511