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Angina PectorisPhase 3CAESANCT01659580

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

A Phase 3 study testing T89 high dose, T89 Low dose and Sanqi+Bingpian in people with Angina Pectoris, run by Tasly Pharmaceuticals, Inc. at 94 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Angina Pectoris
What is being tested?
T89 high dose, T89 Low dose and Sanqi+Bingpian
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,004 participants
Where
94 sitesin 7 countries
Study dates
Aug 2012to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.
  • 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.

Trial locations and contacts

94 sites in 7 countries.

94 sites in 7 countries

United States30 sites

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • Athens Heart Center

    Athens, Georgia, 30606

  • Atlanta Clinical Research Center

    Atlanta, Georgia, 30342

  • Ellipsis Research

    Atlanta, Georgia, 30342

  • Beaver Medical Clinic

    Banning, California, 92220

  • Central Cardiology

    Campbellsville, Kentucky, 42718

  • Hillsboro Cardiology, PC

    Hillsboro, Oregon, 97123

  • Angiocardiac Care of Texas, PA

    Houston, Texas, 77025

  • Northwest Houston Cardiology

    Houston, Texas, 77070

  • Kore CV Research

    Jackson, Tennessee, 38305

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Cardiology Center of Houston, PA

    Katy, Texas, 77450

  • Foundation for Cardiovascular Medicine

    La Jolla, California, 92037

  • Cardiology and Medicine Clinic

    Little Rock, Arkansas, 72204

  • Cleveland Clinic

    Medina, Ohio, 44256

  • Brevard Cardiovascular Research Associates

    Merritt, Florida, 32952

  • SouthCoast Research Center, Inc

    Miami, Florida, 33144

  • Molecular Imaging Research and Clinical Trials

    Miami, Florida, 33156

  • Integrity Clinical Trials

    Miami, Florida, 33165

  • NewPhase Clinical Trials, Inc.

    Miami Beach, Florida, 33140

  • Precision Research Institute

    National City, California, 91950

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

    New Orleans, Louisiana, 70112

  • Manhattan Medical Research Practice

    New York, New York, 10016

  • Peninsula Research, Inc.

    Ormond Beach, Florida, 32174

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239

  • Jedidiah Clinical Research

    Tampa, Florida, 33617

  • Northwest Heart Center

    Tomball, Texas, 77375

  • Paradigm Clinical Research Institute, Inc.

    Torrance, California, 90502

  • Harbor-UCLA Medical Center

    Torrance, California, 90509

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388

Other trials in United States

Russia17 sites

  • Regional Buegetary Healthcare Institution "Cardiological Dispensary"

    Ivanovslaya, Ivanovslaya Obl., 153012

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

    Kemerovo, Russian Federation, 650055

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

    Krasnodar, Russian Federation, 350086

  • Moscow State Healthcare Institution, City Clinical Hospital #15

    Moscow, Russian Federation, 111539

  • First Moscow State Medical University

    Moscow, Russian Federation, 119991

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

    Novosibirsk, Russia, 630087

  • City Polyclinic # 109

    Saint Petersburg, Russian Federation, 192288

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

    Saint Petersburg, Russian Federation, 196601

  • Almazov Federal Heart, Blood And Endocrinology Centre

    Saint Petersburg, Russian Federation, 197341

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

    Saint Petersburg, Russian Federation, 199106

  • Smolensk State Medical Academy Of Roszdrav

    Smolensk, Smoleskaya Oblast, 214019

  • Federal State Budgetary Institution Research Institution Of Cardiology Of Sibirsky

    Tomsk, Tomskaya Obl., 634012

  • Tyumen Cardiology Center

    Tyumen, Russian Federation, 625026

  • City Hospital #4

    Vladimir, Russian Federation, 600020

  • Regional Cardiology Center

    Volgograd, Russia, 400008

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

    Yaroslavl, Russian Federation, 150003

  • Ural Medical Academy

    Yekaterinburg, Russian Federation, 620036

Other trials in Russia

Ukraine16 sites

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

    Ivano-Frankivsk, Ukraine, 76018

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

    Kharkiv, Ukraine, 61039

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

    Kharkiv, Ukraine, 61039

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

    Kiev, Ukraine, 04114

  • Kyiv Oleksandrivska Clinical Hospital

    Kiev, Ukraine, 1601

  • Municipal Clinical Hospital #1

    Kiev, Ukraine, 2091

  • National medical university named after O.O.Bogomolets

    Kiev, Ukraine, 4050

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

    Lviv, Ukraine, 79015

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

    Odesa, Ukraine, 65010

  • City Clinical Hospital No. 3

    Odesa, Ukraine, 65014

  • Odessa regional cardiological dispensary

    Odesa, Ukraine, 65025

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

    Uzhhorod, Ukraine, 88000

  • City Clinical Hospital # 1

    Vinnitsa, Ukraine, 21029

  • Vinnytsya Regional Specialized Center for Radiation Protection of People

    Vinnytsia, Ukraine, 21018

  • Regional medical center of cardiovascular diseases

    Zaporizhzhya, Zaporizhzhia Oblast, 69005

  • Department of internal diseases #2

    Zaporizhzhya, Zaporizhzhia Oblast, 69118

Other trials in Ukraine

Canada14 sites

  • ViaCar Recherche Clinique Inc.

    Brossard, Quebec, J4X 1S4

  • ViaCar Recherche Clinique Inc.

    Greenfield Park, Quebec, J4V 2G8

  • Dr. Petr Polasek, MD, Office of

    Kelowna, British Columbia, V1Y 1V6

  • Centre Cardiovasculaire De La Rive-Sud (Ccrs)

    Longueuil, Quebec, J4M 2X1

  • Dixie Medical Group

    Mississauga, Ontario, L4W 0C2

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Clinique Sante Cardio MC

    Montreal, Quebec, H1T 3Y7

  • The Medical Arts Health Research Group

    North Vancouver, British Columbia, V7L 2P7

  • Bakbak Medicine Professional Corporation

    Oshawa, Ontario, L1H 1B9

  • Heart Care Research

    Oshawa, Ontario, L1J 2J9

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, Quebec, G1V 4G5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

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

    Trois-Rivières, Quebec, G8Z 3R9

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

Georgia8 sites

  • The "Unimed Ajara"

    Batumi, Georgia, 6000

  • Cardiological CLinic "Guli" Ltd

    Tbilisi, Georgia, 0144

  • Archangel St. Michael Multiprofile Clinical Hospital

    Tbilisi, Georgia, 0159

  • Cardio-Reanimation Centre

    Tbilisi, Georgia, 0159

  • Emergency Cardiology Center named by Academician G. Chapidze Ltd

    Tbilisi, Georgia, 0159

  • Tbilis Heart and vascular clinic Ltd.

    Tbilisi, Georgia, 0159

  • Center of Vascular and Heart Diseases Ltd.

    Tbilisi, Georgia, 0160

  • "Clinic L J" Ltd

    Tbilisi, Georgia, 4600

Other trials in Georgia

Mexico8 sites

  • Hospital de Cardiología de Aguascalientes

    Aguascalientes, Aguascalientes, 20230

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

    Culiacán, Sinaloa, 80020

  • Cardiocen de Guadalajara, S.C.

    Guadalajara, Jalisco, 44160

  • Centro de Investigación Clínica Chapultepec

    Morelia, Michoacán, 58260

  • OSMO

    Oaxaca City, Oaxaca, 68000

  • Hospital Central "Dr. Ignacio Morones Prieto"

    San Luis Potosí City, San Luis Potosí, 78240

  • Consultorio Medico de Especialidad

    Tijuana, Estado de Baja California, 22010

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

    Torreón, Coahuila, 27000

Other trials in Mexico

Belarus1 site

  • Minsk Regional Clinical Hospital

    Minsk, Belarus, 223041

Other trials in Belarus

About this study

Official title: Phase III Confirmatory Trial to Confirm the Anti-anginal Effect of Dantonic® (T89) in Patients With Chronic Stable Angina

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.

Read the detailed 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.

Conditions
Angina Pectoris
Being tested
T89 high dose, T89 Low dose, Sanqi+Bingpian, Placebo
Keywords
Angina Pectoris Treatment Prevention
Medical subject headings
Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T89 high doseDrug

    Also called Dantonic®, Compound Danshen Dripping Pills, Salvtonic®

    225mg bid

  • T89 Low doseDrug

    Also called Dantonic®, Salvtonic®, Compound Danshen Dripping Pill

    150mg bid

  • Sanqi+BingpianDrug

    225 mg bid

  • PlaceboDrug

    225mg bid

Study groups in NCT01659580
Study groupRoleWhat they receive
T89 high doseExperimentalT89 225mg bid
Receives: Drug: T89 high dose
T89 low doseExperimentalT89 150mg bid
Receives: Drug: T89 Low dose
Sanqi+BingpianExperimental225mg bid
Receives: Drug: Sanqi+Bingpian
PlaceboPlacebo comparator225mg bid
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (2)

  1. 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;

    Measured: 2nd weeks and 6th weeks

  2. Frequency of weekly angina episodes

    Frequency of weekly angina episodes

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,004 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01659580
Sponsor's protocol ID
T89-07-CAESA
Other IDs
T89-07-GL
Acronym
CAESA
Status last verified
Mar 2017
First submitted
19 Jul 2012
Last updated
9 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32714408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing T89 high dose, T89 Low dose and Sanqi+Bingpian in people with Angina Pectoris, run by Tasly Pharmaceuticals, Inc. at 94 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Russia, Ukraine, Canada, Georgia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of symptom-limited TED from baseline compared to placebo at the end of week 4. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01659580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.

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