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| ID | Type | Description | Link |
|---|---|---|---|
| T89-07-GL | Other Identifier | Tasly Pharmaceuticals INC. |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T89 high dose | Experimental | T89 225mg bid |
|
| T89 low dose | Experimental | T89 150mg bid |
|
| Sanqi+Bingpian | Experimental | 225mg bid |
|
| Placebo | Placebo Comparator | 225mg bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T89 high dose | Drug | 225mg bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of symptom-limited TED at trough drug levels at the end of the 2nd and 6th weeks | The change of symptom-limited TED at trough drug levels at the end of the 2nd and 6th weeks of treatment from screen baseline on Standard Bruce Protocol compared with placebo; | 2nd weeks and 6th weeks |
| Frequency of weekly angina episodes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of angina during Excise Tolerance Test (ETT); | Time to onset of angina during ETT; | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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.
12. 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.
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| Name | Affiliation | Role |
|---|---|---|
| Henry He Sun, PhD | Tasly Group, Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology and Medicine Clinic | Little Rock | Arkansas | 72204 | United States | ||
| Beaver Medical Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32714408 | Derived | 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. |
| Label | URL |
|---|---|
| manufacture and sponsor | View source |
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| T89 Low dose | Drug | 150mg bid |
|
|
| Sanqi+Bingpian | Drug | 225 mg bid |
|
| Placebo | Drug | 225mg bid |
|
Frequency of weekly angina episodes |
| 6 weeks |
| 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 |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C581239 | T89 herbal drug |
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