None listed
Conditions
Brief summary
This is a phase II clinical trial that will use double blind, placebo-controlled, randomized, multi-center, parallel group study design to evaluate the efficacy and safety of T89 in patients with chronic stable angina pectoris.
Interventions
This prospective, double-blind, randomized, multi-center, and placebo-controlled, 2 parallel group phase II trial is to investigate the anti-angina effect of T89 at 187.5 mg, administered orally every 12 hours (daily dose 375 mg) for 8 weeks, while all other concurrent medications for angina pectoris are discontinued except short-acting nitrates (taken as required by patient), beta-blockers or calcium channel blockers, in its ability to enhance exercise tolerance in patients with chronic stable
This prospective, double-blind, randomized, multi-center, and placebo-controlled, 2 parallel group phase II trial is to investigate the anti-angina effect of T89 at 187.5 mg, administered orally every 12 hours (daily dose 375 mg) for 8 weeks, while all other concurrent medications for angina pectoris are discontinued except short-acting nitrates (taken as required by patient), beta-blockers or calcium channel blockers, in its ability to enhance exercise tolerance in patients with chronic stable angina pectoris. Exercise Tolerance Tests (ETTs), Safety checks and frequency of Angina.
Sponsors
CNS Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1.Male or female aged 18 to 80 years. 2.Females of childbearing potential must have a negative pregnancy test, not be breast feeding and established on a method of contraception that in the investigator’s opinion is acceptable. Females must agree to remain on their established method of contraception through their participation in the study. 3.Evidence of coronary artery disease that consists of a well-documented medical history of myocardial infarction or significant coronary artery disease with non-invasive or angiographic confirmation. 4.Symptoms that support the diagnosis of chronic stable angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph changes. 5.Moderate (Class II or Class III according to Canadian Cardiovascular Society Angina Classification) angina pectoris 6.Naive patient or patient who’s Total Exercise Duration (TED) is between 3 to 7 minutes in ETT on Standard Bruce Protocol, and the difference in TED must be no more than 15% between the two screen examinations on day -7 and day 0. 7.Patient must be able to withdraw all anti-angina regimen (except short-acting nitroglycerin, beta-blockers or calcium channel blockers), that were used prior to this initial visit. 8.Patient must understand and be willing to comply with protocol visit schedule. 9.Patient must be able and willing to give informed consent.
Exclusion criteria
1.Contraindication to perform treadmill Exercise Tolerance Test (ETT). 2.Presence of pre-exercise ST-segment depression of at least 1 mm in any lead, left bundle branch block, digoxin therapy, Left Ventricular Hypertrophy (LVH) and Wolff-Parkinson-White (WPW) syndrome or other factors that could, to the investigator’s opinion, interfere with exercise electrocardiograph interpretation. 3.Clinically severe arrhythmias or atrioventricular conduction block greater than first degree. 4.Clinically severe co-morbidities, including hepatic or renal dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, current of cerebral hemorrhage, or seizure disorders that required anticonvulsant medication. 5.Recent history of congestive heart failure (occurrence within two weeks), unstable angina, severe valvular disease, severe hypertension, severe anemia, suspected or known dissecting aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism or recent myocardial infarction within three months of study entry. 6.Current bleeding diathesis, or current treatment with warfarin and/or on other oral anticoagulants, and inability to discontinue these medications. 7.Implanted pacemaker. 8.Aspirin and/or other platelet inhibitors including Clopidogrel, started less than 30 days prior to the signing of informed consent. 9.Pregnancy or lactation. 10.Inability to discontinue existing chronic nitrate regimen (e.g. long acting nitroglycerin) and other anti-angina medications except for beta-blockers or calcium channel blockers. 11.Participation in any other clinical trial or receipt of an investigational drug within 90 days prior to initial visit. 12.Previous participation in this study. 13.Substance abuse. Patients with a recent history (within the last 2 years) of alcoholism or known drug dependence. 14. Patient is a family member or relative of the study site staff. 15. Investigator’s opinion that the individual is not appropriate for the trial
Outcome results
None listed