The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina. Treatment Group A: 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day) Treatment Group B: 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day) Treatment Group C: 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day) Placebo Group: Placebo capsule, 2 capsules t.i.d., after meal
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
186
2 capsules t.i.d., after meal
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan
Chi Mei Medical Center
Tainan, Taiwan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Taipei Medical University-Shuang Ho Hospital
Taipei, Taiwan, Taiwan
Change in Total Exercise Time (Seconds)
the time difference of total exercise time from V2 to V5 compare to placebo
Time frame: 6 weeks after the first exercise tolerance testing is conducted
Change in Time to Onset of Angina From Baseline to the Final Visit
Time frame: 6 weeks
Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit
Time frame: 6 weeks
Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit
Time frame: 6 weeks
Changes in Angina Frequency in Subject's Diary From Baseline to All Visits
Time frame: 6 weeks
Change in Consumption of Short-acting Nitrates From Baseline to All Visits
Time frame: 6 weeks
Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits
Time frame: 6 weeks
Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits
Time frame: 6 weeks
Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.
Time frame: 6 weeks
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Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan