Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina

Completed · Phase 3 · Has a placebo group

Conditions studied: Angina Pectoris

In brief

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 Dantonic® (T89) in patients with chronic stable angina pectoris.

Key facts

Study ID

NCT01659580

Run by

Tasly Pharmaceuticals, Inc.

People needed

1004

Starts

2012-08-01

Expected to finish

2016-12-01

Last updated by the study team

2017-03-09

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent.
• Males and females between the ages of 20 and 80 years.
• 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 and for 14 days following the last dose of study drug.
• Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrolment) 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 III, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System).
• Patient whose symptom-limited Total Exercise Duration (TED) is between 3 to 7 minutes in Exercise Tolerance Test (ETT) on Standard Bruce Protocol, and symptom-limited TED on two screen examinations (Day -7 and 0) in which the shorter is within 85% of the longer .
• Patient has been on one beta-blocker or on one calcium-channel blocker for at least 14 days prior to dosing of study medication 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.
• Understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the verbal rating scales and diary cards.

You may not qualify if…

• With contraindication to, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform treadmill ETT (including, but not limited to: pulmonary hypertension, functionally limiting COPD (chronic obstructive pulmonary disease), history of pulmonary tuberculosis, prior hospitalization for acute exacerbation of chronic lung disease, home oxygen use, chronic oral steroid therapy that can limit exercise capacity, functionally limiting peripheral artery disease, etc.).
• Presence of electrocardiographic or other abnormalities/factors that could interfere with exercise electrocardiograph interpretation or may lead to a false positive stress test (e.g., pre-exercise horizontal or down-sloping ST segment depression in any standard lead, cardiac glycoside therapy, Lown-Ganong-Levine Syndrome, Wolff-Parkinson-White syndrome (WPW), left bundle branch block, left ventricular hypertrophy with repolarization abnormality, implanted pacemaker, etc.).
• Clinically significant arrhythmias or atrioventricular conduction block greater than first degree, decompensated heart failure, atrial fibrillation, hypertrophic cardiomyopathy.
• Acute coronary syndrome (acute myocardial infarction or unstable angina) 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 decompensated congestive heart failure, severe valvular disease, severe uncontrolled hypertension (seated systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg), severe anemia, suspected or known dissecting aortic aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism.
• History of bleeding diathesis, cerebral hemorrhage, or seizure disorders that required anticonvulsant medication.
• Patients requiring the use of long-acting nitroglycerin, ranolazine, and/or multiple anti-anginal drugs.
• Aspirin and/or statins started less than 14 days prior to the signing of informed consent.
• Pregnancy or lactation.
• Clinical trials/experimental medication 1) Participation in any other clinical trial or receipt of an investigational drug within 30 days prior to the initial visit.
• Previous participation in the studies of T89. 11. Substance abuse. Patients with a recent history (within the last 2 years) of alcoholism or known drug dependence.
• Is a family member or relative of the study site staff. 13. Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study.

Where it is running

• Beaver Medical Clinic — Banning, California, United States
• Foundation for Cardiovascular Medicine — La Jolla, California, United States
• Precision Research Institute — National City, California, United States
• Paradigm Clinical Research Institute, Inc. — Torrance, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Brevard Cardiovascular Research Associates — Merritt, Florida, United States
• SouthCoast Research Center, Inc — Miami, Florida, United States
• Molecular Imaging Research and Clinical Trials — Miami, Florida, United States
• Integrity Clinical Trials — Miami, Florida, United States
• NewPhase Clinical Trials, Inc. — Miami Beach, Florida, United States
• Peninsula Research, Inc. — Ormond Beach, Florida, United States
• Cardiovascular Center of Sarasota — Sarasota, Florida, United States
• Jedidiah Clinical Research — Tampa, Florida, United States
• Athens Heart Center — Athens, Georgia, United States
• Atlanta Clinical Research Center — Atlanta, Georgia, United States
• Ellipsis Research — Atlanta, Georgia, United States
• Central Cardiology — Campbellsville, Kentucky, United States
• Alexandria Cardiology Clinic — Alexandria, Louisiana, United States
• Tulane University Health Science Center, Tulane University Heart & Vascular Institute — New Orleans, Louisiana, United States
• Manhattan Medical Research Practice — New York, New York, United States
• Cleveland Clinic — Medina, Ohio, United States
• Hillsboro Cardiology, PC — Hillsboro, Oregon, United States
• Kore CV Research — Jackson, Tennessee, United States
• Cardiology and Medicine Clinic — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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