Phase II Multi-Center Study of T89 to Treat Chronic Stable Angina
NCT ID: NCT00797953
Last Updated: 2012-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2007-02-28
2010-01-31
Brief Summary
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Detailed Description
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The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore, Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose response of T89 in patients with chronic stable angina pectoris in the United States.
T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN) as active constitutes, and using Borneol as transporting enhancer.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low dose
2 capsules of T89 with 1 placebo capsule each time, twice daily. The daily dose is 250 mg.
T89
A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
High dose
3 capsules of T89 each time, twice daily. The daily dose is 375 mg
T89
A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
Placebo
3 placebo capsules (PC) each time, twice per day. The daily dose is 0 mg.
T89
A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
Interventions
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T89
A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation.
4. 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.
5. Moderate angina pectoris (Class II or Class III, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System)
6. Naive patient or patient who's Total Exercise Duration (TED) is between 3 to 7 minutes in ETT on Standard Bruce Protocol, and the difference in TED must be no more than 15% between the two screen examinations on day -7 and day 0
7. All anti-angina regimen (except short-acting nitroglycerin, and one beta-blocker or calcium channel blocker), warfarin or other oral anticoagulants which were used prior to this initial visit can be discontinued.
8. Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the verbal rating scales and diary cards.
9. Patient must be able to give voluntary written informed consent.
Exclusion Criteria
2. Pre-exercise ST-segment depression of at least 1 mm in any lead, left bundle branch block, digoxin therapy, Left Ventricular Hypertrophy (LVH) and Wolff-Parkinson-White (WPW) syndrome or other factors that could interfere with exercise electrocardiograph interpretation.
3. Clinically significant arrhythmias or atrioventricular conduction block greater than first degree.
4. Clinically significant co-morbidities, including hepatic or renal dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage, or seizure disorders that required anticonvulsant medication.
5. History of congestive heart failure, unstable angina, severe valvular disease, severe hypertension, severe anemia, suspected or known dissecting aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism or recent myocardial infarction within three months of study entry.
6. History of bleeding diathesis, or is on warfarin.
7. Implanted pacemaker.
8. Aspirin and/or statins started less than 14 days prior to the signing of informed consent.
9. Pregnancy or lactation.
10. Inability to discontinue existing chronic nitrate regimen (e.g. long acting nitroglycerin) and allow only short-acting nitroglycerin and one beta-blocker or calcium channel blocker.
11. Clinical trials/experimental medication:
* Participation in any other clinical trial or receipt of an investigational drug within 90 days prior to initial visit.
* Those patients unable, in the opinion of the investigator, to comply fully with the trial requirements.
* Previous participation in this study.
12. Substance abuse. Patients with a recent history (within the last 2 years) of alcoholism or known drug dependence.
13. Patient is a family member or relative of the study site staff.
18 Years
80 Years
ALL
No
Sponsors
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Tasly Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jason Zhixin Guo, MD
Role: STUDY_DIRECTOR
Tasly Pharmaceuticals Co. Ltd.
Locations
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Paradigm Clinical, Inc.
Tucson, Arizona, United States
Robert M. Karns, A Medical Corporation
Beverly Hills, California, United States
Inland Heart Doctors
Corona, California, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
Cardiovascular Research Center of South Florida
Miami, Florida, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States
Great Lakes Research Group, Inc
Bay City, Michigan, United States
Marc Kozinn Associates
Williamsville, New York, United States
Oklahoma Cardiovascular & Hypertension
Oklahoma City, Oklahoma, United States
Three Rivers Medical Associates
Columbia, South Carolina, United States
East Texas Cardiology
Houston, Texas, United States
Northwest Houston Cardiology
Houston, Texas, United States
Northwest Heart Center
Tomball, Texas, United States
National Clinical Research-Norfolk, Inc
Norfolk, Virginia, United States
Gemini Scientific, LLC
Madison, Wisconsin, United States
Countries
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Related Links
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Manufacture
Other Identifiers
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T89-005-0003-US
Identifier Type: -
Identifier Source: org_study_id