Clinical Trial: Phase IIb Study of STA-2 in Patients With Chronic Stable Angina
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Dose-Response and Safety of STA-2 in Patients With Chronic Stable Angina
Brief Summary: 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.
Detailed Summary:
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
Sponsor: Sinphar Pharmaceutical Co., Ltd
Current Primary Outcome: Change in Total Exercise Time (Seconds) [ Time Frame: 6 weeks after the first exercise tolerance testing is conducted ]
Original Primary Outcome: Change in total exercise time [ Time Frame: 6 weeks after the first exercise tolerance testing is conducted ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- 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 ]
Information By: Sinphar Pharmaceutical Co., Ltd
Dates:
Date Received: November 10, 2010
Date Started: November 2010
Date Completion:
Last Updated: August 13, 2014
Last Verified: August 2014