Clinical Trial: Phase II Multi-Center Study of T89 to Treat Chronic Stable Angina

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Pec

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Tasly Pharmaceuticals, Inc.

Current Primary Outcome: 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 ]

Original Primary Outcome: 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: 8 weeks ]

Current Secondary Outcome: Frequency of weekly angina episodes [ Time Frame: 12 weeks ]

Original Secondary Outcome: Frequency of weekly angina episodes [ Time Frame: 8 weeks ]

Information By: Tasly Pharmaceuticals, Inc.

Dates:
Date Received: November 24, 2008
Date Started: February 2007
Date Completion:
Last Updated: December 10, 2012
Last Verified: December 2012