Phase II Multi-Center Study of T89 to Treat Chronic Stable Angina (T89 phase 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00797953
First received: November 24, 2008
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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
Angina Pectoris
Drug: T89
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tasly Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Total Exercise Duration (TED) change from screen baseline value in Exercise Tolerance Test (ETT) on Standard Bruce Protocol at trough drug levels at the end of the 4th and 8th week of treatment compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of weekly angina episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: February 2007
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
2 capsules of T89 with 1 placebo capsule each time, twice daily. The daily dose is 250 mg.
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.
Other Names:
  • Dantonic Capsule
  • Cardiotonic Pills
Experimental: High dose
3 capsules of T89 each time, twice daily. The daily dose is 375 mg
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.
Other Names:
  • Dantonic Capsule
  • Cardiotonic Pills
Placebo Comparator: Placebo
3 placebo capsules (PC) each time, twice per day. The daily dose is 0 mg.
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.
Other Names:
  • Dantonic Capsule
  • Cardiotonic Pills

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797953

Locations
United States, Arizona
Paradigm Clinical, Inc.
Tucson, Arizona, United States, 85705
United States, California
Robert M. Karns, A Medical Corporation
Beverly Hills, California, United States, 90211
Inland Heart Doctors
Corona, California, United States, 92879
United States, Florida
Sunrise Medical Research
Lauderdale Lakes, Florida, United States, 33319
Cardiovascular Research Center of South Florida
Miami, Florida, United States, 33173
United States, Louisiana
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States, 71301
United States, Michigan
Great Lakes Research Group, Inc
Bay City, Michigan, United States, 48706
United States, New York
Marc Kozinn Associates
Williamsville, New York, United States, 14221
United States, Oklahoma
Oklahoma Cardiovascular & Hypertension
Oklahoma, Oklahoma, United States, 73132
United States, South Carolina
Three Rivers Medical Associates
Columbia, South Carolina, United States, 29201
United States, Texas
East Texas Cardiology
Houston, Texas, United States, 77002
Northwest Houston Cardiology
Houston, Texas, United States, 77070
Northwest Heart Center
Tomball, Texas, United States, 77375
United States, Virginia
National Clinical Research-Norfolk, Inc
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Gemini Scientific, LLC
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Tasly Pharmaceuticals, Inc.
Investigators
Study Director: Jason Zhixin Guo, MD Tasly Pharmaceuticals Co. Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00797953     History of Changes
Other Study ID Numbers: T89-005-0003-US
Study First Received: November 24, 2008
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Tasly Pharmaceuticals, Inc.:
Angina Pectoris Treatment

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014