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 ]

the time difference of total exercise time from V2 to V5 compare to placebo


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