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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01659580
Other study ID # T89-07-CAESA
Secondary ID T89-07-GL
Status Completed
Phase Phase 3
First received July 19, 2012
Last updated March 7, 2017
Start date August 2012
Est. completion date December 2016

Study information

Verified date March 2017
Source Tasly Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1004
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 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.

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 significant coronary artery disease with noninvasive or angiographic confirmation.

5. 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.

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

7. 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 .

8. 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.

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

Exclusion Criteria:

1. 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.).

2. 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.).

3. Clinically significant arrhythmias or atrioventricular conduction block greater than first degree, decompensated heart failure, atrial fibrillation, hypertrophic cardiomyopathy.

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 coronary revascularization during the study period.

5. 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.

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

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

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

9. Pregnancy or lactation.

10. 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.

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
T89 high dose
225mg bid
T89 Low dose
150mg bid
Sanqi+Bingpian
225 mg bid
Placebo
225mg bid

Locations

Country Name City State
Belarus Minsk Regional Clinical Hospital Minsk
Canada ViaCar Recherche Clinique Inc. Brossard Quebec
Canada ViaCar Recherche Clinique Inc. Greenfield Park Quebec
Canada Dr. Petr Polasek, MD, Office of Kelowna British Columbia
Canada Centre Cardiovasculaire De La Rive-Sud (Ccrs) Longueuil Quebec
Canada Dixie Medical Group Mississauga Ontario
Canada Clinique Sante Cardio MC Montreal Quebec
Canada Montreal Heart Institute Montreal Quebec
Canada The Medical Arts Health Research Group North Vancouver British Columbia
Canada Bakbak Medicine Professional Corporation Oshawa Ontario
Canada Heart Care Research Oshawa Ontario
Canada Institut Universitaire de Cardiologie et de Pneumologie de Quebec Quebec
Canada St. Michael's Hospital Toronto Ontario
Canada Centre de Sante et de Services Sociaux de Trois-Rivieres Trois-Rivieres Quebec
Canada Victoria Heart Institute Foundation Victoria British Columbia
Georgia The "Unimed Ajara" Batumi
Georgia "Clinic L J" Ltd Tbilisi
Georgia Archangel St. Michael Multiprofile Clinical Hospital Tbilisi
Georgia Cardio-Reanimation Centre Tbilisi
Georgia Cardiological CLinic "Guli" Ltd Tbilisi
Georgia Center of Vascular and Heart Diseases Ltd. Tbilisi
Georgia Emergency Cardiology Center named by Academician G. Chapidze Ltd Tbilisi
Georgia Tbilis Heart and vascular clinic Ltd. Tbilisi
Mexico Hospital de Cardiología de Aguascalientes Aguascalientes
Mexico Centro para el Desarollo de la Medicina y de Asistencia Medica Esp. S.C. Culiacan Sinaloa
Mexico Cardiocen de Guadalajara, S.C. Guadalajara Jalisco
Mexico Centro de Investigación Clínica Chapultepec Morelia Michoacán
Mexico OSMO Oaxaca
Mexico Hospital Central "Dr. Ignacio Morones Prieto" San Luis Potosí SLP
Mexico Consultorio Medico de Especialidad Tijuana Baja California
Mexico Centro para el Desarrollo de la Medicina y Asistencia Médica Especializada SC sede Torreon Coahuila Torreón Coahuila
Russian Federation Ural Medical Academy Ekaterinburg
Russian Federation Regional Buegetary Healthcare Institution "Cardiological Dispensary" Ivanovslaya Ivanovslaya Obl.
Russian Federation Nonstate Healthcare Institution "Departmental Clinical Hospital on Kemerovo Station of Public Corporation "Russian Railroad" Kemerovo
Russian Federation Krasnodar regional hospital #1 n.a. Prof. Ochapovskiy S.V. Krasnodar
Russian Federation First Moscow State Medical University Moscow
Russian Federation Moscow State Healthcare Institution, City Clinical Hospital #15 Moscow
Russian Federation State Budgetary Healthcare Institution "State Novosibirsk Regional Clinical Hospital" Novosibirsk Russia
Russian Federation Almazov Federal Heart, Blood And Endocrinology Centre Saint-Petersburg
Russian Federation Smolensk State Medical Academy Of Roszdrav Smolensk Smoleskaya oblast
Russian Federation Almazov Federal Heart, Blood And Endocrinology Centre St. Petersburg
Russian Federation City Hospital #38 named after Semashko N.A. St. Petersburg
Russian Federation City Polyclinic # 109 St. Petersburg
Russian Federation St. Petersburg State Health Care, Institution Pokrovskaya City Hospital St. Petersburg
Russian Federation Federal State Budgetary Institution Research Institution Of Cardiology Of Sibirsky Tomsk Tomskaya Obl.
Russian Federation Tyumen Cardiology Center Tyumen
Russian Federation City Hospital #4 Vladimir
Russian Federation Regional Cardiology Center Volgograd Russia
Russian Federation Clinical Hospital n.a. N.V. Solovyov Yaroslavl
Ukraine Ivano-Frankivsk Regional Clinical Cardiology Dispensary, department of anesthesiology with intensive care unit Ivano-Frankivsk
Ukraine L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine Kharkiv
Ukraine L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine, Head of Cardiopulmonology Department Government Institution Kharkiv
Ukraine Institute Of Gerontology, Department Of Clinical Physiology And Pathology Of Internal Organs Kiev
Ukraine Kyiv Oleksandrivska Clinical Hospital Kiev
Ukraine Municipal Clinical Hospital #1 Kiev
Ukraine National medical university named after O.O.Bogomolets Kiev
Ukraine Lviv Regional State Clinical Threatment-and-Diagnostic Cardiology Center Lviv
Ukraine City Clinical Hospital No. 3 Odessa
Ukraine Department of Family Medicine and General Practice of Odessa National Medical University Odessa
Ukraine Odessa regional cardiological dispensary Odessa
Ukraine District Clinical Hospital Of Station "Uzhgorod", Dgto "Lviv Railway Station" Therapeutic Department Uzhgorod
Ukraine City Clinical Hospital # 1 Vinnitsa
Ukraine Vinnytsya Regional Specialized Center for Radiation Protection of People Vinnytsya
Ukraine Department of internal diseases #2 Zaporizhzhya Zaporizhzhya region
Ukraine Regional medical center of cardiovascular diseases Zaporizhzhya Zaporizhzhya region
United States Alexandria Cardiology Clinic Alexandria Louisiana
United States Athens Heart Center Athens Georgia
United States Atlanta Clinical Research Center Atlanta Georgia
United States Ellipsis Research Atlanta Georgia
United States Beaver Medical Clinic Banning California
United States Central Cardiology Campbellsville Kentucky
United States Hillsboro Cardiology, PC Hillsboro Oregon
United States Angiocardiac Care of Texas, PA Houston Texas
United States Northwest Houston Cardiology Houston Texas
United States Kore CV Research Jackson Tennessee
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States Cardiology Center of Houston, PA Katy Texas
United States Foundation for Cardiovascular Medicine La Jolla California
United States Cardiology and Medicine Clinic Little Rock Arkansas
United States Cleveland Clinic Medina Ohio
United States Brevard Cardiovascular Research Associates Merritt Florida
United States Integrity Clinical Trials Miami Florida
United States Molecular Imaging Research and Clinical Trials Miami Florida
United States SouthCoast Research Center, Inc Miami Florida
United States NewPhase Clinical Trials, Inc. Miami Beach Florida
United States Precision Research Institute National City California
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 Peninsula Research, Inc. Ormond Beach Florida
United States Cardiovascular Center of Sarasota Sarasota Florida
United States Jedidiah Clinical Research Tampa Florida
United States Northwest Heart Center Tomball Texas
United States Harbor-UCLA Medical Center Torrance California
United States Paradigm Clinical Research Institute, Inc. Torrance California
United States Tennessee Center for Clinical Trials Tullahoma Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Tasly Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Canada,  Georgia,  Mexico,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Other Time to onset of angina during Excise Tolerance Test (ETT); Time to onset of angina during ETT; 6 weeks
Primary 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 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
Secondary Frequency of weekly angina episodes Frequency of weekly angina episodes 6 weeks
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