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

Last updated: March 7, 2017
Sponsor: Tasly Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Chest Pain

Acute Pain

Treatment

N/A

Clinical Study ID

NCT01659580
T89-07-CAESA
T89-07-GL
  • Ages 20-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent.

  2. Males and females between the ages of 20 and 80 years.

  3. Females of childbearing potential must have a negative pregnancy test, not be breastfeeding and established on a method of contraception that in the investigator'sopinion is acceptable. Females must agree to remain on their established method ofcontraception through their participation in the study and for 14 days following thelast dose of study drug.

  4. Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrolment) of myocardial infarction or significantcoronary artery disease with noninvasive or angiographic confirmation.

  5. Symptoms that support the diagnosis of chronic angina and/or a history of an abnormalexercise response limited by angina and/or electrocardiograph (ECG) changes.

  6. Moderate angina pectoris (Class II or III, Grading of Angina Pectoris by the CanadianCardiovascular Society Classification System).

  7. Patient whose symptom-limited Total Exercise Duration (TED) is between 3 to 7 minutesin Exercise Tolerance Test (ETT) on Standard Bruce Protocol, and symptom-limited TEDon two screen examinations (Day -7 and 0) in which the shorter is within 85% of thelonger .

  8. Patient has been on one beta-blocker or on one calcium-channel blocker for at least 14days prior to dosing of study medication and can remain on this treatment throughoutthe study as background anti-anginal treatment. Short-acting nitroglycerin foron-demand use is allowed for all eligible patients.

  9. Understand and be willing, able and likely to comply with all study procedures andrestrictions and comprehends the verbal rating scales and diary cards.

Exclusion

Exclusion Criteria:

  1. With contraindication to, unable to, or with other co-morbidities that may prevent orinterfere with the ability to perform treadmill ETT (including, but not limited to:pulmonary hypertension, functionally limiting COPD (chronic obstructive pulmonarydisease), history of pulmonary tuberculosis, prior hospitalization for acuteexacerbation of chronic lung disease, home oxygen use, chronic oral steroid therapythat can limit exercise capacity, functionally limiting peripheral artery disease,etc.).

  2. Presence of electrocardiographic or other abnormalities/factors that could interferewith exercise electrocardiograph interpretation or may lead to a false positive stresstest (e.g., pre-exercise horizontal or down-sloping ST segment depression in anystandard lead, cardiac glycoside therapy, Lown-Ganong-Levine Syndrome,Wolff-Parkinson-White syndrome (WPW), left bundle branch block, left ventricularhypertrophy with repolarization abnormality, implanted pacemaker, etc.).

  3. Clinically significant arrhythmias or atrioventricular conduction block greater thanfirst degree, decompensated heart failure, atrial fibrillation, hypertrophiccardiomyopathy.

  4. Acute coronary syndrome (acute myocardial infarction or unstable angina) in the prior 2 months or coronary revascularization within the prior 6 months or planned coronaryrevascularization during the study period.

  5. Congenital cardiac defects, ongoing history of decompensated congestive heart failure,severe valvular disease, severe uncontrolled hypertension (seated systolic bloodpressure > 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.

  6. History of bleeding diathesis, cerebral hemorrhage, or seizure disorders that requiredanticonvulsant medication.

  7. Patients requiring the use of long-acting nitroglycerin, ranolazine, and/or multipleanti-anginal drugs.

  8. Aspirin and/or statins started less than 14 days prior to the signing of informedconsent.

  9. Pregnancy or lactation.

  10. Clinical trials/experimental medication 1) Participation in any other clinical trialor receipt of an investigational drug within 30 days prior to the initial visit.

  1. Previous participation in the studies of T89. 11. Substance abuse. Patients with arecent history (within the last 2 years) of alcoholism or known drug dependence.
  1. 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 studyprotocol or pose a safety concern if the subject participates in the study.

Study Design

Total Participants: 1004
Study Start date:
August 01, 2012
Estimated Completion Date:
December 31, 2016

Study 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.

Connect with a study center

  • Minsk Regional Clinical Hospital

    Minsk, 223041
    Belarus

    Site Not Available

  • Dr. Petr Polasek, MD, Office of

    Kelowna, British Columbia V1Y 1V6
    Canada

    Site Not Available

  • The Medical Arts Health Research Group

    North Vancouver, British Columbia V7L 2P7
    Canada

    Site Not Available

  • Victoria Heart Institute Foundation

    Victoria, British Columbia V8R 4R2
    Canada

    Site Not Available

  • Dixie Medical Group

    Mississauga, Ontario L4W 0C2
    Canada

    Site Not Available

  • Bakbak Medicine Professional Corporation

    Oshawa, Ontario L1H 1B9
    Canada

    Site Not Available

  • Heart Care Research

    Oshawa, Ontario L1J 2J9
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • ViaCar Recherche Clinique Inc.

    Brossard, Quebec J4X 1S4
    Canada

    Site Not Available

  • ViaCar Recherche Clinique Inc.

    Greenfield Park, Quebec J4V 2G8
    Canada

    Site Not Available

  • Centre Cardiovasculaire De La Rive-Sud (Ccrs)

    Longueuil, Quebec J4M 2X1
    Canada

    Site Not Available

  • Clinique Sante Cardio MC

    Montreal, Quebec H1T 3Y7
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Centre de Sante et de Services Sociaux de Trois-Rivieres

    Trois-Rivieres, Quebec G8Z 3R9
    Canada

    Site Not Available

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Quebec, G1V 4G5
    Canada

    Site Not Available

  • The "Unimed Ajara"

    Batumi, 6000
    Georgia

    Site Not Available

  • "Clinic L J" Ltd

    Tbilisi, 4600
    Georgia

    Site Not Available

  • Archangel St. Michael Multiprofile Clinical Hospital

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Cardio-Reanimation Centre

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Cardiological CLinic "Guli" Ltd

    Tbilisi, 0144
    Georgia

    Site Not Available

  • Center of Vascular and Heart Diseases Ltd.

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Emergency Cardiology Center named by Academician G. Chapidze Ltd

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Tbilis Heart and vascular clinic Ltd.

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Under Contracting

    Multiple Citis,
    Japan

    Site Not Available

  • Consultorio Medico de Especialidad

    Tijuana, Baja California 22010
    Mexico

    Site Not Available

  • Centro para el Desarrollo de la Medicina y Asistencia Médica Especializada SC sede Torreon Coahuila

    Torreón, Coahuila 27000
    Mexico

    Site Not Available

  • Cardiocen de Guadalajara, S.C.

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Centro de Investigación Clínica Chapultepec

    Morelia, Michoacán 58260
    Mexico

    Site Not Available

  • Hospital Central "Dr. Ignacio Morones Prieto"

    San Luis Potosí, SLP 78240
    Mexico

    Site Not Available

  • Centro para el Desarollo de la Medicina y de Asistencia Medica Esp. S.C.

    Culiacan, Sinaloa 80020
    Mexico

    Site Not Available

  • Hospital de Cardiología de Aguascalientes

    Aguascalientes, 20230
    Mexico

    Site Not Available

  • OSMO

    Oaxaca, 68000
    Mexico

    Site Not Available

  • Regional Buegetary Healthcare Institution "Cardiological Dispensary"

    Ivanovslaya, Ivanovslaya Obl. 153012
    Russian Federation

    Site Not Available

  • State Budgetary Healthcare Institution "State Novosibirsk Regional Clinical Hospital"

    Novosibirsk, Russia 630087
    Russian Federation

    Site Not Available

  • Regional Cardiology Center

    Volgograd, Russia 400008
    Russian Federation

    Site Not Available

  • Smolensk State Medical Academy Of Roszdrav

    Smolensk, Smoleskaya oblast 214019
    Russian Federation

    Site Not Available

  • Federal State Budgetary Institution Research Institution Of Cardiology Of Sibirsky

    Tomsk, Tomskaya Obl. 634012
    Russian Federation

    Site Not Available

  • Ural Medical Academy

    Ekaterinburg, 620036
    Russian Federation

    Site Not Available

  • Nonstate Healthcare Institution "Departmental Clinical Hospital on Kemerovo Station of Public Corporation "Russian Railroad"

    Kemerovo, 650055
    Russian Federation

    Site Not Available

  • Krasnodar regional hospital #1 n.a. Prof. Ochapovskiy S.V.

    Krasnodar, 350086
    Russian Federation

    Site Not Available

  • First Moscow State Medical University

    Moscow, 119991
    Russian Federation

    Site Not Available

  • Moscow State Healthcare Institution, City Clinical Hospital #15

    Moscow, 111539
    Russian Federation

    Site Not Available

  • Almazov Federal Heart, Blood And Endocrinology Centre

    Saint-Petersburg, 197341
    Russian Federation

    Site Not Available

  • Almazov Federal Heart, Blood And Endocrinology Centre

    St. Petersburg, 197341
    Russian Federation

    Site Not Available

  • City Hospital #38 named after Semashko N.A.

    St. Petersburg, 196601
    Russian Federation

    Site Not Available

  • City Polyclinic # 109

    St. Petersburg, 192288
    Russian Federation

    Site Not Available

  • St. Petersburg State Health Care, Institution Pokrovskaya City Hospital

    St. Petersburg, 199106
    Russian Federation

    Site Not Available

  • Tyumen Cardiology Center

    Tyumen, 625026
    Russian Federation

    Site Not Available

  • City Hospital #4

    Vladimir, 600020
    Russian Federation

    Site Not Available

  • Clinical Hospital n.a. N.V. Solovyov

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Department of internal diseases #2

    Zaporizhzhya, Zaporizhzhya region 69118
    Ukraine

    Site Not Available

  • Regional medical center of cardiovascular diseases

    Zaporizhzhya, Zaporizhzhya region 69005
    Ukraine

    Site Not Available

  • Ivano-Frankivsk Regional Clinical Cardiology Dispensary, department of anesthesiology with intensive care unit

    Ivano-Frankivsk, 76018
    Ukraine

    Site Not Available

  • L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine, Head of Cardiopulmonology Department Government Institution

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • Institute Of Gerontology, Department Of Clinical Physiology And Pathology Of Internal Organs

    Kiev, 04114
    Ukraine

    Site Not Available

  • Kyiv Oleksandrivska Clinical Hospital

    Kiev, 1601
    Ukraine

    Site Not Available

  • Municipal Clinical Hospital #1

    Kiev, 2091
    Ukraine

    Site Not Available

  • National medical university named after O.O.Bogomolets

    Kiev, 4050
    Ukraine

    Site Not Available

  • Lviv Regional State Clinical Threatment-and-Diagnostic Cardiology Center

    Lviv, 79015
    Ukraine

    Site Not Available

  • City Clinical Hospital No. 3

    Odessa, 65014
    Ukraine

    Site Not Available

  • Department of Family Medicine and General Practice of Odessa National Medical University

    Odessa, 65010
    Ukraine

    Site Not Available

  • Odessa regional cardiological dispensary

    Odessa, 65025
    Ukraine

    Site Not Available

  • District Clinical Hospital Of Station "Uzhgorod", Dgto "Lviv Railway Station" Therapeutic Department

    Uzhgorod, 88000
    Ukraine

    Site Not Available

  • City Clinical Hospital # 1

    Vinnitsa, 21029
    Ukraine

    Site Not Available

  • Vinnytsya Regional Specialized Center for Radiation Protection of People

    Vinnytsya, 21018
    Ukraine

    Site Not Available

  • Cardiology and Medicine Clinic

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • Beaver Medical Clinic

    Banning, California 92220
    United States

    Site Not Available

  • Foundation for Cardiovascular Medicine

    La Jolla, California 92037
    United States

    Site Not Available

  • Precision Research Institute

    National City, California 91950
    United States

    Site Not Available

  • Harbor-UCLA Medical Center

    Torrance, California 90509
    United States

    Site Not Available

  • Paradigm Clinical Research Institute, Inc.

    Torrance, California 90502
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Brevard Cardiovascular Research Associates

    Merritt, Florida 32952
    United States

    Site Not Available

  • Integrity Clinical Trials

    Miami, Florida 33165
    United States

    Site Not Available

  • Molecular Imaging Research and Clinical Trials

    Miami, Florida 33156
    United States

    Site Not Available

  • SouthCoast Research Center, Inc

    Miami, Florida 33144
    United States

    Site Not Available

  • NewPhase Clinical Trials, Inc.

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Peninsula Research, Inc.

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Cardiovascular Center of Sarasota

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Jedidiah Clinical Research

    Tampa, Florida 33617
    United States

    Site Not Available

  • Athens Heart Center

    Athens, Georgia 30606
    United States

    Site Not Available

  • Atlanta Clinical Research Center

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Ellipsis Research

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Central Cardiology

    Campbellsville, Kentucky 42718
    United States

    Site Not Available

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Tulane University Health Science Center, Tulane University Heart & Vascular Institute

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Contract

    Multiple Cities, New York
    United States

    Site Not Available

  • Manhattan Medical Research Practice

    New York, New York 10016
    United States

    Site Not Available

  • Cleveland Clinic

    Medina, Ohio 44256
    United States

    Site Not Available

  • Hillsboro Cardiology, PC

    Hillsboro, Oregon 97123
    United States

    Site Not Available

  • Kore CV Research

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • Angiocardiac Care of Texas, PA

    Houston, Texas 77025
    United States

    Site Not Available

  • Northwest Houston Cardiology

    Houston, Texas 77070
    United States

    Site Not Available

  • Cardiology Center of Houston, PA

    Katy, Texas 77450
    United States

    Site Not Available

  • Northwest Heart Center

    Tomball, Texas 77375
    United States

    Site Not Available

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