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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Chronic Stable Angina	Drug: green tea polyphenols (STA-2)	Phase 2

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	186 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	November 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	April 2012

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo group; placebo capsule 2# t.i.d./day	Drug: green tea polyphenols (STA-2); 2 capsules t.i.d., after meal
Experimental: Treatment Group A; 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)	Drug: green tea polyphenols (STA-2); 2 capsules t.i.d., after meal
Experimental: Treatment Group B; 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)	Drug: green tea polyphenols (STA-2); 2 capsules t.i.d., after meal
Experimental: Treatment Group C; 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)	Drug: green tea polyphenols (STA-2); 2 capsules t.i.d., after meal

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Change in Time to Onset of Angina From Baseline to the Final Visit [ Time Frame: 6 weeks ]
2. Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit [ Time Frame: 6 weeks ]
3. Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit [ Time Frame: 6 weeks ]
4. Changes in Angina Frequency in Subject's Diary From Baseline to All Visits [ Time Frame: 6 weeks ]
5. Change in Consumption of Short-acting Nitrates From Baseline to All Visits [ Time Frame: 6 weeks ]
6. Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits [ Time Frame: 6 weeks ]
7. Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits [ Time Frame: 6 weeks ]
8. Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time. [ Time Frame: 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

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, Taiwan

Sponsors and Collaborators

Sinphar Pharmaceutical Co., Ltd

Investigators

Principal Investigator:	Chuen-Den Tseng, MD, Ph.D	Department of Cardiology National Taiwan University Hospital

More Information

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Responsible Party:	Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT01239511 History of Changes
Other Study ID Numbers:	MCCD09004A
First Posted:	November 11, 2010
Results First Posted:	August 27, 2014
Last Update Posted:	August 27, 2014
Last Verified:	August 2014

Additional relevant MeSH terms:

Angina Pectoris; Angina, Stable; Chest Pain; Pain; Neurologic Manifestations; Nervous System Diseases	Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Signs and Symptoms