NCT01659580

Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina

Phase III Confirmatory Trial to Confirm the Anti-anginal Effect of Dantonic® (T89) in Patients With Chronic Stable Angina

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,004 (actual)
• Sponsor: Tasly Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This phase III study is designed as a double blind, randomized, multi-nation, multi-center, placebo controlled clinical research, which aims to evaluate the safety and efficacy of Dantonic® (T89) in patients with chronic stable angina pectoris.

Detailed description

Dantonic® (T89) is a botanical drug consists of extracts of Danshen (Radix Salviae Miltiorrhizae) and Sanqi (Radix Notoginseng) with borneol in a capsule form. The drug is currently approved in 26 countries outside the USA for the treatment and prevention of chronic stable angina pectoris and other cardiovascular disease related conditions. This pivotal confirmative Phase III clinical trial is to confirm the efficacy and safety of the drug at 150mg and 225mg doses in the prevention and treatment of angina pectoris in patients with Chronic Stable Angina. The contribution of the main herb Danshen to, and the difference of various production batches in, the overall efficacy and safety profiles will also be explored. Patients will take a morning and an evening dose orally (every 12 hours) for 6 weeks while stop taking any long-acting nitroglycerin, ranolazine, and/or multiple beta-blockers or beta blocker(s) with calcium channel blocker during the trial. Single beta-blocker and/or on-demand short acting nitroglycerin to relief angina pectoris is allowed during the trial. After physical exams and if eligible to participation, patients will stop taking other drugs, and undergo two baseline screen Exercise Treadmill Tests (ETT) on Standard Bruce Protocol in the clinic one week before and right before starting the drug treatment. Patients will perform three more ETTs before the morning dose at the end of week 2, 4 and 6 after receiving the drug treatment. The primary efficiency endpoint is the change of symptom-limited Total Exercise Duration of the ETT at the end of the 4th week of treatment from the average of the two screening baselines compared with that of placebo treatment.

Conditions

• Angina Pectoris

Interventions

Type	Name	Description
DRUG	T89 high dose	225mg bid
DRUG	T89 Low dose	150mg bid
DRUG	Sanqi+Bingpian	225 mg bid
DRUG	Placebo	225mg bid

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-08-08
• Last updated: 2017-03-09

Locations

94 sites across 7 countries: United States, Belarus, Canada, Georgia, Mexico, Russia, Ukraine