Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina
This trial is active, not recruiting.
|Treatments||t89 high dose, t89 low dose, sanqi+bingpian, placebo|
|Sponsor||Tasly Pharmaceuticals, Inc.|
|Start date||August 2012|
|End date||March 2016|
|Trial size||960 participants|
|Trial identifier||NCT01659580, T89-07-CAESA, T89-07-GL|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Little Rock, AR||Cardiology and Medicine Clinic||no longer recruiting|
|Banning, CA||Beaver Medical Clinic||no longer recruiting|
|La Jolla, CA||Foundation for Cardiovascular Medicine||no longer recruiting|
|National City, CA||Precision Research Institute||no longer recruiting|
|Torrance, CA||Paradigm Clinical Research Institute, Inc.||no longer recruiting|
|Torrance, CA||Harbor-UCLA Medical Center||no longer recruiting|
|Jacksonville, FL||Jacksonville Center for Clinical Research||no longer recruiting|
|Merritt, FL||Brevard Cardiovascular Research Associates||no longer recruiting|
|Miami Beach, FL||NewPhase Clinical Trials, Inc.||no longer recruiting|
|Miami, FL||SouthCoast Research Center, Inc||no longer recruiting|
|Miami, FL||Molecular Imaging Research and Clinical Trials||no longer recruiting|
|Miami, FL||Integrity Clinical Trials||no longer recruiting|
|Ormond Beach, FL||Peninsula Research, Inc.||no longer recruiting|
|Sarasota, FL||Cardiovascular Center of Sarasota||no longer recruiting|
|Tampa, FL||Jedidiah Clinical Research||no longer recruiting|
|Athens, GA||Athens Heart Center||no longer recruiting|
|Atlanta, GA||Atlanta Clinical Research Center||no longer recruiting|
|Atlanta, GA||Ellipsis Research||no longer recruiting|
|Campbellsville, KY||Central Cardiology||no longer recruiting|
|Alexandria, LA||Alexandria Cardiology Clinic||no longer recruiting|
|New Orleans, LA||Tulane University Health Science Center, Tulane University Heart & Vascular Institute||no longer recruiting|
|New York, NY||Manhattan Medical Research Practice||no longer recruiting|
|Medina, OH||Cleveland Clinic||no longer recruiting|
|Hillsboro, OR||Hillsboro Cardiology, PC||no longer recruiting|
|Jackson, TN||Kore CV Research||no longer recruiting|
|Tullahoma, TN||Tennessee Center for Clinical Trials||no longer recruiting|
|Houston, TX||Angiocardiac Care of Texas, PA||no longer recruiting|
|Houston, TX||Northwest Houston Cardiology||no longer recruiting|
|Katy, TX||Cardiology Center of Houston, PA||no longer recruiting|
|Tomball, TX||Northwest Heart Center||no longer recruiting|
|Minsk, Belarus||Minsk Regional Clinical Hospital||no longer recruiting|
|Kelowna, Canada||Dr. Petr Polasek, MD, Office of||no longer recruiting|
|North Vancouver, Canada||The Medical Arts Health Research Group||no longer recruiting|
|Victoria, Canada||Victoria Heart Institute Foundation||no longer recruiting|
|Mississauga, Canada||Dixie Medical Group||no longer recruiting|
|Oshawa, Canada||Bakbak Medicine Professional Corporation||no longer recruiting|
|Oshawa, Canada||Heart Care Research||no longer recruiting|
|Toronto, Canada||St. Michael's Hospital||no longer recruiting|
|Brossard, Canada||ViaCar Recherche Clinique Inc.||no longer recruiting|
|Greenfield Park, Canada||ViaCar Recherche Clinique Inc.||no longer recruiting|
|Longueuil, Canada||Centre Cardiovasculaire De La Rive-Sud (Ccrs)||no longer recruiting|
|Montreal, Canada||Montreal Heart Institute||no longer recruiting|
|Montreal, Canada||Clinique Sante Cardio MC||no longer recruiting|
|Trois-Rivieres, Canada||Centre de Sante et de Services Sociaux de Trois-Rivieres||no longer recruiting|
|Quebec, Canada||Institut Universitaire de Cardiologie et de Pneumologie de Quebec||no longer recruiting|
|Batumi, Georgia||The "Unimed Ajara"||no longer recruiting|
|Tbilisi, Georgia||Cardiological CLinic "Guli" Ltd||no longer recruiting|
|Tbilisi, Georgia||Archangel St. Michael Multiprofile Clinical Hospital||no longer recruiting|
|Tbilisi, Georgia||Cardio-Reanimation Centre||no longer recruiting|
|Tbilisi, Georgia||Emergency Cardiology Center named by Academician G. Chapidze Ltd||no longer recruiting|
|Tbilisi, Georgia||Tbilis Heart and vascular clinic Ltd.||no longer recruiting|
|Tbilisi, Georgia||Center of Vascular and Heart Diseases Ltd.||no longer recruiting|
|Tbilisi, Georgia||"Clinic L J" Ltd||no longer recruiting|
|Tijuana, Mexico||Consultorio Medico de Especialidad||no longer recruiting|
|Torreón, Mexico||Centro para el Desarrollo de la Medicina y Asistencia Médica Especializada SC sede Torreon Coahuila||no longer recruiting|
|Guadalajara, Mexico||Cardiocen de Guadalajara, S.C.||no longer recruiting|
|Morelia, Mexico||Centro de Investigación Clínica Chapultepec||no longer recruiting|
|Culiacan, Mexico||Centro para el Desarollo de la Medicina y de Asistencia Medica Esp. S.C.||no longer recruiting|
|San Luis Potosí, Mexico||Hospital Central "Dr. Ignacio Morones Prieto"||no longer recruiting|
|Aguascalientes, Mexico||Hospital de Cardiología de Aguascalientes||no longer recruiting|
|Oaxaca, Mexico||OSMO||no longer recruiting|
|Ivanovslaya, Russian Federation||Regional Buegetary Healthcare Institution "Cardiological Dispensary"||no longer recruiting|
|Novosibirsk, Russian Federation||State Budgetary Healthcare Institution "State Novosibirsk Regional Clinical Hospital"||no longer recruiting|
|Volgograd, Russian Federation||Regional Cardiology Center||no longer recruiting|
|Smolensk, Russian Federation||Smolensk State Medical Academy Of Roszdrav||no longer recruiting|
|Tomsk, Russian Federation||Federal State Budgetary Institution Research Institution Of Cardiology Of Sibirsky||no longer recruiting|
|Ekaterinburg, Russian Federation||Ural Medical Academy||no longer recruiting|
|Kemerovo, Russian Federation||Nonstate Healthcare Institution "Departmental Clinical Hospital on Kemerovo Station of Public Corporation "Russian Railroad"||no longer recruiting|
|Krasnodar, Russian Federation||Krasnodar regional hospital #1 n.a. Prof. Ochapovskiy S.V.||no longer recruiting|
|Moscow, Russian Federation||Moscow State Healthcare Institution, City Clinical Hospital #15||no longer recruiting|
|Moscow, Russian Federation||First Moscow State Medical University||no longer recruiting|
|Saint-Petersburg, Russian Federation||Almazov Federal Heart, Blood And Endocrinology Centre||no longer recruiting|
|St. Petersburg, Russian Federation||City Polyclinic # 109||no longer recruiting|
|St. Petersburg, Russian Federation||City Hospital #38 named after Semashko N.A.||no longer recruiting|
|St. Petersburg, Russian Federation||Almazov Federal Heart, Blood And Endocrinology Centre||no longer recruiting|
|St. Petersburg, Russian Federation||St. Petersburg State Health Care, Institution Pokrovskaya City Hospital||no longer recruiting|
|Tyumen, Russian Federation||Tyumen Cardiology Center||no longer recruiting|
|Vladimir, Russian Federation||City Hospital #4||no longer recruiting|
|Yaroslavl, Russian Federation||Clinical Hospital n.a. N.V. Solovyov||no longer recruiting|
|Zaporizhzhya, Ukraine||Regional medical center of cardiovascular diseases||no longer recruiting|
|Zaporizhzhya, Ukraine||Department of internal diseases #2||no longer recruiting|
|Ivano-Frankivsk, Ukraine||Ivano-Frankivsk Regional Clinical Cardiology Dispensary, department of anesthesiology with intensive care unit||no longer recruiting|
|Kharkiv, Ukraine||L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine, Head of Cardiopulmonology Department Government Institution||no longer recruiting|
|Kharkiv, Ukraine||L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine||no longer recruiting|
|Kiev, Ukraine||Institute Of Gerontology, Department Of Clinical Physiology And Pathology Of Internal Organs||no longer recruiting|
|Kiev, Ukraine||Kyiv Oleksandrivska Clinical Hospital||no longer recruiting|
|Kiev, Ukraine||Municipal Clinical Hospital #1||no longer recruiting|
|Kiev, Ukraine||National medical university named after O.O.Bogomolets||no longer recruiting|
|Lviv, Ukraine||Lviv Regional State Clinical Threatment-and-Diagnostic Cardiology Center||no longer recruiting|
|Odessa, Ukraine||Department of Family Medicine and General Practice of Odessa National Medical University||no longer recruiting|
|Odessa, Ukraine||City Clinical Hospital No. 3||no longer recruiting|
|Odessa, Ukraine||Odessa regional cardiological dispensary||no longer recruiting|
|Uzhgorod, Ukraine||District Clinical Hospital Of Station "Uzhgorod", Dgto "Lviv Railway Station" Therapeutic Department||no longer recruiting|
|Vinnitsa, Ukraine||City Clinical Hospital # 1||no longer recruiting|
|Vinnytsya, Ukraine||Vinnytsya Regional Specialized Center for Radiation Protection of People||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
T89 225mg bid
T89 150mg bid
The change of symptom-limited TED from baseline compared to placebo at the end of week 4.
time frame: 4 weeks
The change of symptom-limited TED at trough drug levels at the end of the 2nd and 6th weeks
time frame: 2nd weeks and 6th weeks
Frequency of weekly angina episodes
time frame: 6 weeks
Male or female participants from 20 years up to 80 years old.
- 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.
- 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. 2) 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.
|Official title||Phase III Confirmatory Trial to Confirm the Anti-anginal Effect of Dantonic® (T89) in Patients With Chronic Stable Angina|
|Description||Dantonic® (T89) is a botanical drug consists of extracts of Danshen (Radix Salviae Miltiorrhizae) and Sanqi (Radix Notoginseng) with borneol in a capsule form. The drug is currently approved in 26 countries outside the USA for the treatment and prevention of chronic stable angina pectoris and other cardiovascular disease related conditions. This pivotal confirmative Phase III clinical trial is to confirm the efficacy and safety of the drug at 150mg and 225mg doses in the prevention and treatment of angina pectoris in patients with Chronic Stable Angina. The contribution of the main herb Danshen to, and the difference of various production batches in, the overall efficacy and safety profiles will also be explored. Patients will take a morning and an evening dose orally (every 12 hours) for 6 weeks while stop taking any long-acting nitroglycerin, ranolazine, and/or multiple beta-blockers or beta blocker(s) with calcium channel blocker during the trial. Single beta-blocker and/or on-demand short acting nitroglycerin to relief angina pectoris is allowed during the trial. After physical exams and if eligible to participation, patients will stop taking other drugs, and undergo two baseline screen Exercise Treadmill Tests (ETT) on Standard Bruce Protocol in the clinic one week before and right before starting the drug treatment. Patients will perform three more ETTs before the morning dose at the end of week 2, 4 and 6 after receiving the drug treatment. The primary efficiency endpoint is the change of symptom-limited Total Exercise Duration of the ETT at the end of the 4th week of treatment from the average of the two screening baselines compared with that of placebo treatment.|
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