Phase II Multi-Center Study of T89 to Treat Chronic Stable Angina
Status: | Completed |
---|---|
Conditions: | Angina, Angina |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 10/14/2017 |
Start Date: | February 2007 |
End Date: | January 2010 |
A Phase II, Double Blind, Placebo-controlled, Randominzed, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of T89 in Patient With Chronic Stable Angina Pectoris
The purpose of this study is to determine the anti-angina effect and dose response of T89, a
2-herb botanical drug product, in patients with chronic stable angina pectoris in the United
States.
2-herb botanical drug product, in patients with chronic stable angina pectoris in the United
States.
T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89
was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due
to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993.
There were more than 2 billion doses have been prescribed or used, in about 10,000,000
subjects, in short or long-term administration worldwide.
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.
was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due
to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993.
There were more than 2 billion doses have been prescribed or used, in about 10,000,000
subjects, in short or long-term administration worldwide.
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.
Inclusion Criteria:
1. Patient must be between the ages of 18 and 80 years.
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:
1. With contraindication to perform treadmill Exercise Tolerance Test (ETT).
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.
We found this trial at
15
sites
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