Phase 2
N=186
Phase IIb Study of STA-2 in Patients With Chronic Stable Angina
Chronic Stable Angina
Bottom Line
View on ClinicalTrials.gov: NCT01239511 ↗Enrolled (actual)
186
Serious AEs
1.6%
Results posted
Aug 2014
Primary outcome: Primary: Change in Total Exercise Time (Seconds) — 24.3; 18.2; 33.9; 11.9 second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- green tea polyphenols (STA-2) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Sinphar Pharmaceutical Co., Ltd
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Exercise Time (Seconds) |
24.3; 18.2; 33.9; 11.9 | — |
| SECONDARY Change in Time to Onset of Angina From Baseline to the Final Visit |
— | — |
| SECONDARY Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit |
— | — |
| SECONDARY Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit |
— | — |
| SECONDARY Changes in Angina Frequency in Subject's Diary From Baseline to All Visits |
— | — |
| SECONDARY Change in Consumption of Short-acting Nitrates From Baseline to All Visits |
— | — |
| SECONDARY Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits |
— | — |
| SECONDARY Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits |
— | — |
| SECONDARY Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time. |
— | — |
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
- Male or female aged ≧ 20 years;
- Subjects weight > 50 kg
- subjects who had more than 50% coronary stenosis documented by catheterization or ever received coronary intervention;
- 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;
- The difference in exercise duration between screening (Visit 1) and baseline (Visit 2) do not exceed 20% of the longer test;
- Able to provide written informed consent.
Exclusion Criteria
- Subjects with pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
- Subjects with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, subjects who need digoxin or digitalis;
- Subjects with any resting EKG abnormalities preventing the interpretation of ischemia as judged by the investigator;
- Subjects with COPD requiring bronchodilators;
- 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;
- Subjects with documented evidence of gastroduodenal ulcer disease, gastrointestinal bleeding or other gastrointestinal disease within the preceding 3 months as judged by investigator;
- 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;
- Subject with any conditions that could interfere the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stoke);
- Female subjects of childbearing potential who:
- are lactating;
- have positive pregnancy test (urine) at V1;
- Subject has received any investigational agent within 28 days prior to the first dose of investigational product;
- Subjects who have had administered STA-2 in prior clinical trial.
Data sourced from ClinicalTrials.gov (NCT01239511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.