Chronic Stable Angina Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of STA-2 in Patients With Chronic Stable Angina
The objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.
The primary objective of this study was to evaluate the efficacy of STA-2 in the management
of chronic stable angina. The secondary objectives of this study were to evaluate the safety
and pharmacological activities of STA-2 in the management of chronic stable angina. This was
a multi-center, double-blind, randomized, parallel-group, placebo-controlled study of STA-2
in the management of chronic stable angina. The study period for each patient was
approximately 7 weeks, during which the patient undergone one-week screening and washout
period, followed by 6 weeks of treatment. Each patient was required to make a total of 5
visits. Primary Efficacy Endpoint: Change in total exercise time.
After washout, patients who met the inclusion and exclusion criteria were randomly assigned
either to the treatment or control group. The respective regimens were:
Treatment group:
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules ter in die
(t.i.d.=three times daily) for 6 weeks, to be administered in a non-fasting state.
Control group:
Placebo 250 mg capsule, 2 capsules t.i.d. (three times daily) for 6 weeks, to be
administered in a non-fasting state.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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