Status:
COMPLETED
Phase IIb Study of STA-2 in Patients With Chronic Stable Angina
Lead Sponsor:
Sinphar Pharmaceutical Co., Ltd
Conditions:
Chronic Stable Angina
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01239511
Start Date
November 1 2010
End Date
April 1 2012
Last Update
August 27 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan
2
Chi Mei Medical Center
Tainan, Taiwan, Taiwan
3
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
4
Taipei Medical University-Shuang Ho Hospital
Taipei, Taiwan, Taiwan