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

Chronic Stable Angina Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239511
• Other study ID #: MCCD09004A
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2010
• Last updated: August 13, 2014
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: August 2014
• Source: Sinphar Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Male or female aged ? 20 years;

2. Subjects weight > 50 kg

3. subjects who had more than 50% coronary stenosis documented by catheterization or ever received coronary intervention;

4. The two ETT results at screening (Visit 1) and baseline (Visit 2) show greater than or equal to 1 mm ST-segment depression within exercise duration;

5. The difference in exercise duration between screening (Visit 1) and baseline (Visit 2) do not exceed 20% of the longer test;

6. Able to provide written informed consent.

Exclusion Criteria:

1. Subjects with pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;

2. Subjects with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, subjects who need digoxin or digitalis;

3. Subjects with any resting EKG abnormalities preventing the interpretation of ischemia as judged by the investigator;

4. Subjects with COPD requiring bronchodilators;

5. Subjects with impaired hepatic function (defined as AST or ALT > 2X the upper limit of normal values), or impaired renal function (defined as serum creatinine > 1.5 mg/dL), or diagnosis of any chronic renal/hepatic disease;

6. Subjects with documented evidence of gastroduodenal ulcer disease, gastrointestinal bleeding or other gastrointestinal disease within the preceding 3 months as judged by investigator;

7. Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with safety assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, or hematological disease as determined by the clinical judgment of the investigator;

8. Subject with any conditions that could interfere the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stoke);

9. Female subjects of childbearing potential who:

• are lactating;

• have positive pregnancy test (urine) at V1;

10. Subject has received any investigational agent within 28 days prior to the first dose of investigational product;

11. Subjects who have had administered STA-2 in prior clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Stable Angina

Intervention

Drug:
• green tea polyphenols (STA-2)
2 capsules t.i.d., after meal

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University-Shuang Ho Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Sinphar Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Exercise Time (Seconds)	the time difference of total exercise time from V2 to V5 compare to placebo	6 weeks after the first exercise tolerance testing is conducted	No
Secondary	Change in Time to Onset of Angina From Baseline to the Final Visit		6 weeks	No
Secondary	Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit		6 weeks	No
Secondary	Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit		6 weeks	No
Secondary	Changes in Angina Frequency in Subject's Diary From Baseline to All Visits		6 weeks	No
Secondary	Change in Consumption of Short-acting Nitrates From Baseline to All Visits		6 weeks	No
Secondary	Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits		6 weeks	No
Secondary	Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits		6 weeks	No
Secondary	Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.		6 weeks	No