NCT00797953

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Tasly Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Angina Pectoris

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2008-11-25
• Last updated: 2012-12-12

Locations

15 sites across 1 country: United States