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Sponsored by: |
Tasly Pharmaceuticals, Inc. |
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Information provided by: | Tasly Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00797953 |
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.
Condition | Intervention | Phase |
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Angina Pectoris |
Drug: T89 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 108 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Low dose: Experimental
2 capsules of T89 with 1 placebo capsule each time, twice daily. The daily dose is 250 mg.
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Drug: T89
A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
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High dose: Experimental
3 capsules of T89 each time, twice daily. The daily dose is 375 mg
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Drug: T89
A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
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Placebo: Placebo Comparator
3 placebo capsules (PC) each time, twice per day. The daily dose is 0 mg.
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Drug: T89
A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Clinical trials/experimental medication:
Contact: Jenny Wike, Ph.D | (281)-367-6655 | JWike@inventivclinical.com |
Contact: Mrinalini Bilgi, ms | (281)-367-6655 | MBilgi@inventivclinical.com |
United States, Arizona | |
Paradigm Clinical, Inc. | Recruiting |
Tucson, Arizona, United States, 85705 | |
Contact: Aimee Bachelier, MD 520-829-6675 abachelier@paradigmclinical.com | |
United States, California | |
Inland Heart Doctors | Recruiting |
Corona, California, United States, 92879 | |
Contact: Maged Gayed 951-734-9519 | |
United States, Louisiana | |
Alexandria Cardiology Clinic | Recruiting |
Alexandria, Louisiana, United States, 71301 | |
Contact: Naseem Jaffrani | |
United States, Texas | |
Northwest Heart Center | Recruiting |
Tomball, Texas, United States, 77375 | |
Contact: Syed Naqvi 281-517-0550 syed@dynamedcr.com | |
East Texas Cardiology | Recruiting |
Houston, Texas, United States, 77002 | |
Contact: Aijaz Hussain 832-885-7723 |
Study Director: | Jason Zhixin Guo, MD | Tasly Pharmaceuticals Co. Ltd. |
Responsible Party: | inVentiv Clinical Solusions ( Jenny Wike ) |
Study ID Numbers: | T89-005-0003-US |
Study First Received: | November 24, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00797953 |
Health Authority: | United States: Food and Drug Administration |
Angina Pectoris Treatment |
Signs and Symptoms Heart Diseases Myocardial Ischemia Vascular Diseases |
Angina Pectoris Pain Ischemia Chest Pain |
Cardiovascular Diseases |