Status:
COMPLETED
Phase II 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 objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.
Detailed Description
The primary objective of this study was to evaluate the efficacy of STA-2 in the management of chronic stable angina. The secondary objectives of this study were to evaluate the safety and pharmacolog...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female aged \> 20;
- Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction ≥ 3 months before screening;
- Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening (Day -7);
- Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by \>20% in total exercise time;
- Female patient who was in the post-menopausal stage or of childbearing potential who:
- used adequate contraception since last menstruation and no plan for conception during the study;
- was non-lactating;
- had negative pregnancy test (urine) within 14 days prior to the study;
- Able to provide written informed consent.
- Exclusion criteria:
- Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
- Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator;
- Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);
- Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;
- Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) \> 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine \> 3 mg/dL);
- Patients with severe gastrointestinal illness as judged by the investigator;
- Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01484912
Start Date
May 1 2007
End Date
June 1 2008
Last Update
December 6 2011
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Chi Mei Medical Center
Tainan, Tainan, Taiwan
2
National Taiwan University Hospital
Taipei, Taipei, Taiwan
3
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan