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

CompletedPhase 2NCT01484912
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 objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.

Study details

Official title
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of STA-2 in Patients With Chronic Stable Angina
Interventions
Sponsor
Sinphar Pharmaceutical Co., Ltd
Start date
2007-05
Primary completion
2008-06
Sex
All
Age range
from 20 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Taiwan
Total sites listed
3

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion criteria: 1. Male or female aged \> 20; 2. 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; 3. 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); 4. 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; 5. 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; 6. Able to provide written informed consent. Exclusion criteria: 1. Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months; 2. 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; 3. Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block); 4. Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators; 5. 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); 6. Patients with severe gastrointestinal illness as judged by the investigator; 7. Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01484912