Last updated on November 2017

Traditional Chinese Herbal Capsule to Prevent and Treat Stable Angina


Brief description of study

Traditional Chinese Herbal Capsule to Prevent and Treat Stable Angina

Detailed Study Description

This phase III study is designed as a double blind, randomized, multi-nation, multi-center, placebo controlled clinical research, which aims to evaluate the safety and efficacy of (T89) in patients with chronic stable angina pectoris.

Patient Inclusion Criteria:

  • Males and Females between the ages 20 and 80 years
  • Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation.
  • Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes.
  • Moderate angina pectoris (Class II or Class III)
  • Patient whose symptom-limited Total Exercise Duration (TED) is between 3 to 7 minutes in ETT on Standard Bruce Protocol, and symptom-limited TED on two screen examinations (Day -7 and Day 0) in which the shorter is within 85% of the longer.
  • Patient has been on one beta-blocker or one calcium channel blocker for at least 14 days prior to T89 dosing and can remain on this treatment throughout the study as background anti-anginal treatment. Short acting nitroglycerin for on-demand use is allowed for all eligible patients.

Patient Exclusion Criteria:

  • With contraindication, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform treadmill Exercise Tolerance Test (ETT).
  • Presence of electrocardiographic or other abnormalities/factors that could interfere with exercise electrocardiograph interpretation or may lead to a false positive stress test.
  • Clinically significant arrhythmias or atrioventricular conduction block greater than first degree, decompensated heart failure, atrial fibrillation,hypertrophic cardiomyopathy.
  • Acute coronary syndrome in the prior 2 months or coronary revascularization within the prior 6 months or planned coronary revascularization during the study period.
  • Congenital cardiac defects, ongoing history of congestive heart failure, unstable angina, severe valvular disease, severe uncontrolled 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.
  • History of bleeding diathesis, cerebral hemorrhage, or seizure disorders that required anticonvulsant medication.
  • Aspirin and/or statins started less than 14 days prior to the signing of informed consent.
  • Other protocol specific inclusion/exclusion criteria apply

Clinical Study Identifier: TX13238

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Lauraine Crandall

Cardiology Research Associates
Daytona Beach, FL USA
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