NCT01239511

Phase IIb Study of STA-2 in Patients With Chronic Stable Angina

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Dose-Response and Safety of STA-2 in Patients With Chronic Stable Angina

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Sinphar Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Chronic Stable Angina

Interventions

Type	Name	Description
DRUG	green tea polyphenols (STA-2)	2 capsules t.i.d., after meal

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-11-11
• Last updated: 2014-08-27
• Results posted: 2014-08-27

Locations

5 sites across 1 country: Taiwan