TerminatedPhase 2ACTRN12609000044224

A Phase II, Double Blind, Placebo-controlled, Randomized, Multi-Center, Parallel Group Study to Evaluate The Efficacy and Safety of T89, drug name: Dantonic 'Registered trade mark' in Patients with Chronic Stable Angina Pectoris

A Phase II, Study to Evaluate The Efficacy and Safety of Dantonic 'Registered trade mark' in Patients with Chronic Stable Angina Pectoris


Sponsor

CNS Pty Ltd

Enrollment

70 participants

Start Date

Jun 12, 2008

Study Type

Interventional

Conditions

Summary

This is a phase II clinical trial that will use double blind, placebo-controlled, randomized, multi-center, parallel group study design to evaluate the efficacy and safety of T89 in patients with chronic stable angina pectoris.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a traditional Chinese medicine called T89 (Dantonic) for people with chronic stable chest pain caused by heart disease. It is for adults aged 18 to 80 who have confirmed coronary artery disease and experience moderate angina. Participation involves taking the study drug or a placebo and performing treadmill exercise tests to measure improvement.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This prospective, double-blind, randomized, multi-center, and placebo-controlled, 2 parallel group phase II trial is to investigate the anti-angina effect of T89 at 187.5 mg, administered orally every

This prospective, double-blind, randomized, multi-center, and placebo-controlled, 2 parallel group phase II trial is to investigate the anti-angina effect of T89 at 187.5 mg, administered orally every 12 hours (daily dose 375 mg) for 8 weeks, while all other concurrent medications for angina pectoris are discontinued except short-acting nitrates (taken as required by patient), beta-blockers or calcium channel blockers, in its ability to enhance exercise tolerance in patients with chronic stable angina pectoris. Exercise Tolerance Tests (ETTs), Safety checks and frequency of Angina.


Locations(1)

New Zealand

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