Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina
CAESA
Phase III Confirmatory Trial to Confirm the Anti-anginal Effect of Dantonic® (T89) in Patients With Chronic Stable Angina
2 other identifiers
interventional
1,004
7 countries
94
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2012
Typical duration for phase_3
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 9, 2017
March 1, 2017
4.3 years
July 19, 2012
March 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change of symptom-limited TED from baseline compared to placebo at the end of week 4.
The change of symptom-limited Total Exercise Duration (TED) at trough drug levels at the end of the 4th week of treatment from screen baseline on Standard Bruce Protocol compared with placebo.
4 weeks
Secondary Outcomes (2)
The change of symptom-limited TED at trough drug levels at the end of the 2nd and 6th weeks
2nd weeks and 6th weeks
Frequency of weekly angina episodes
6 weeks
Other Outcomes (1)
Time to onset of angina during Excise Tolerance Test (ETT);
6 weeks
Study Arms (4)
T89 high dose
EXPERIMENTALT89 225mg bid
T89 low dose
EXPERIMENTALT89 150mg bid
Sanqi+Bingpian
EXPERIMENTAL225mg bid
Placebo
PLACEBO COMPARATOR225mg bid
Interventions
225mg bid
150mg bid
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204, United States
Beaver Medical Clinic
Banning, California, 92220, United States
Foundation for Cardiovascular Medicine
La Jolla, California, 92037, United States
Precision Research Institute
National City, California, 91950, United States
Paradigm Clinical Research Institute, Inc.
Torrance, California, 90502, United States
Harbor-UCLA Medical Center
Torrance, California, 90509, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Brevard Cardiovascular Research Associates
Merritt, Florida, 32952, United States
SouthCoast Research Center, Inc
Miami, Florida, 33144, United States
Molecular Imaging Research and Clinical Trials
Miami, Florida, 33156, United States
Integrity Clinical Trials
Miami, Florida, 33165, United States
NewPhase Clinical Trials, Inc.
Miami Beach, Florida, 33140, United States
Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239, United States
Jedidiah Clinical Research
Tampa, Florida, 33617, United States
Athens Heart Center
Athens, Georgia, 30606, United States
Atlanta Clinical Research Center
Atlanta, Georgia, 30342, United States
Ellipsis Research
Atlanta, Georgia, 30342, United States
Central Cardiology
Campbellsville, Kentucky, 42718, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, 71301, United States
Tulane University Health Science Center, Tulane University Heart & Vascular Institute
New Orleans, Louisiana, 70112, United States
Manhattan Medical Research Practice
New York, New York, 10016, United States
Cleveland Clinic
Medina, Ohio, 44256, United States
Hillsboro Cardiology, PC
Hillsboro, Oregon, 97123, United States
Kore CV Research
Jackson, Tennessee, 38305, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388, United States
Angiocardiac Care of Texas, PA
Houston, Texas, 77025, United States
Northwest Houston Cardiology
Houston, Texas, 77070, United States
Cardiology Center of Houston, PA
Katy, Texas, 77450, United States
Northwest Heart Center
Tomball, Texas, 77375, United States
Minsk Regional Clinical Hospital
Minsk, Belarus, 223041, Belarus
Dr. Petr Polasek, MD, Office of
Kelowna, British Columbia, V1Y 1V6, Canada
The Medical Arts Health Research Group
North Vancouver, British Columbia, V7L 2P7, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2, Canada
Dixie Medical Group
Mississauga, Ontario, L4W 0C2, Canada
Bakbak Medicine Professional Corporation
Oshawa, Ontario, L1H 1B9, Canada
Heart Care Research
Oshawa, Ontario, L1J 2J9, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
ViaCar Recherche Clinique Inc.
Brossard, Quebec, J4X 1S4, Canada
ViaCar Recherche Clinique Inc.
Greenfield Park, Quebec, J4V 2G8, Canada
Centre Cardiovasculaire De La Rive-Sud (Ccrs)
Longueuil, Quebec, J4M 2X1, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Clinique Sante Cardio MC
Montreal, Quebec, H1T 3Y7, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5, Canada
Centre de Sante et de Services Sociaux de Trois-Rivieres
Trois-Rivières, Quebec, G8Z 3R9, Canada
The "Unimed Ajara"
Batumi, Georgia, 6000, Georgia
Cardiological CLinic "Guli" Ltd
Tbilisi, Georgia, 0144, Georgia
Archangel St. Michael Multiprofile Clinical Hospital
Tbilisi, Georgia, 0159, Georgia
Cardio-Reanimation Centre
Tbilisi, Georgia, 0159, Georgia
Emergency Cardiology Center named by Academician G. Chapidze Ltd
Tbilisi, Georgia, 0159, Georgia
Tbilis Heart and vascular clinic Ltd.
Tbilisi, Georgia, 0159, Georgia
Center of Vascular and Heart Diseases Ltd.
Tbilisi, Georgia, 0160, Georgia
"Clinic L J" Ltd
Tbilisi, Georgia, 4600, Georgia
Hospital de Cardiología de Aguascalientes
Aguascalientes, Aguascalientes, 20230, Mexico
Centro para el Desarrollo de la Medicina y Asistencia Médica Especializada SC sede Torreon Coahuila
Torreón, Coahuila, 27000, Mexico
Consultorio Medico de Especialidad
Tijuana, Estado de Baja California, 22010, Mexico
Cardiocen de Guadalajara, S.C.
Guadalajara, Jalisco, 44160, Mexico
Centro de Investigación Clínica Chapultepec
Morelia, Michoacán, 58260, Mexico
OSMO
Oaxaca City, Oaxaca, 68000, Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, 78240, Mexico
Centro para el Desarollo de la Medicina y de Asistencia Medica Esp. S.C.
Culiacán, Sinaloa, 80020, Mexico
Regional Buegetary Healthcare Institution "Cardiological Dispensary"
Ivanovslaya, Ivanovslaya Obl., 153012, Russia
Nonstate Healthcare Institution "Departmental Clinical Hospital on Kemerovo Station of Public Corporation "Russian Railroad"
Kemerovo, Russian Federation, 650055, Russia
Krasnodar regional hospital #1 n.a. Prof. Ochapovskiy S.V.
Krasnodar, Russian Federation, 350086, Russia
Moscow State Healthcare Institution, City Clinical Hospital #15
Moscow, Russian Federation, 111539, Russia
First Moscow State Medical University
Moscow, Russian Federation, 119991, Russia
City Polyclinic # 109
Saint Petersburg, Russian Federation, 192288, Russia
City Hospital #38 named after Semashko N.A.
Saint Petersburg, Russian Federation, 196601, Russia
Almazov Federal Heart, Blood And Endocrinology Centre
Saint Petersburg, Russian Federation, 197341, Russia
St. Petersburg State Health Care, Institution Pokrovskaya City Hospital
Saint Petersburg, Russian Federation, 199106, Russia
Tyumen Cardiology Center
Tyumen, Russian Federation, 625026, Russia
City Hospital #4
Vladimir, Russian Federation, 600020, Russia
Clinical Hospital n.a. N.V. Solovyov
Yaroslavl, Russian Federation, 150003, Russia
Ural Medical Academy
Yekaterinburg, Russian Federation, 620036, Russia
State Budgetary Healthcare Institution "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, Russia, 630087, Russia
Regional Cardiology Center
Volgograd, Russia, 400008, Russia
Smolensk State Medical Academy Of Roszdrav
Smolensk, Smoleskaya Oblast, 214019, Russia
Federal State Budgetary Institution Research Institution Of Cardiology Of Sibirsky
Tomsk, Tomskaya Obl., 634012, Russia
Ivano-Frankivsk Regional Clinical Cardiology Dispensary, department of anesthesiology with intensive care unit
Ivano-Frankivsk, Ukraine, 76018, Ukraine
L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine, Head of Cardiopulmonology Department Government Institution
Kharkiv, Ukraine, 61039, Ukraine
L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine
Kharkiv, Ukraine, 61039, Ukraine
Institute Of Gerontology, Department Of Clinical Physiology And Pathology Of Internal Organs
Kiev, Ukraine, 04114, Ukraine
Kyiv Oleksandrivska Clinical Hospital
Kiev, Ukraine, 1601, Ukraine
Municipal Clinical Hospital #1
Kiev, Ukraine, 2091, Ukraine
National medical university named after O.O.Bogomolets
Kiev, Ukraine, 4050, Ukraine
Lviv Regional State Clinical Threatment-and-Diagnostic Cardiology Center
Lviv, Ukraine, 79015, Ukraine
Department of Family Medicine and General Practice of Odessa National Medical University
Odesa, Ukraine, 65010, Ukraine
City Clinical Hospital No. 3
Odesa, Ukraine, 65014, Ukraine
Odessa regional cardiological dispensary
Odesa, Ukraine, 65025, Ukraine
District Clinical Hospital Of Station "Uzhgorod", Dgto "Lviv Railway Station" Therapeutic Department
Uzhhorod, Ukraine, 88000, Ukraine
City Clinical Hospital # 1
Vinnitsa, Ukraine, 21029, Ukraine
Vinnytsya Regional Specialized Center for Radiation Protection of People
Vinnytsia, Ukraine, 21018, Ukraine
Regional medical center of cardiovascular diseases
Zaporizhzhya, Zaporizhzhia Oblast, 69005, Ukraine
Department of internal diseases #2
Zaporizhzhya, Zaporizhzhia Oblast, 69118, Ukraine
Related Publications (1)
Shi Y, Liu D, Yuan J, Yan L, Zhan Z, Pan D, Lin L, Mu B. Compound Danshen Dripping Pills Prevented Leptin Deficiency-Induced Hepatic ER Stress, Stimulated Autophagy, and Improved Insulin Resistance of ob/ob Mice. Evid Based Complement Alternat Med. 2020 Jul 3;2020:5368657. doi: 10.1155/2020/5368657. eCollection 2020.
PMID: 32714408DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henry He Sun, PhD
Tasly Group, Co. Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2012
First Posted
August 8, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 9, 2017
Record last verified: 2017-03