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

NCT ID: NCT01484912

Last Updated: 2011-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-06-30

Brief Summary

The objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.

Detailed Description

The primary objective of this study was to evaluate the efficacy of STA-2 in the management of chronic stable angina. The secondary objectives of this study were to evaluate the safety and pharmacological activities of STA-2 in the management of chronic stable angina. This was a multi-center, double-blind, randomized, parallel-group, placebo-controlled study of STA-2 in the management of chronic stable angina. The study period for each patient was approximately 7 weeks, during which the patient undergone one-week screening and washout period, followed by 6 weeks of treatment. Each patient was required to make a total of 5 visits. Primary Efficacy Endpoint: Change in total exercise time.

After washout, patients who met the inclusion and exclusion criteria were randomly assigned either to the treatment or control group. The respective regimens were:

Treatment group:

STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules ter in die (t.i.d.=three times daily) for 6 weeks, to be administered in a non-fasting state.

Control group:

Placebo 250 mg capsule, 2 capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.

Conditions

Chronic Stable Angina

Keywords

Green tea polyphenols; Chronic Stable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

STA-2

STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.

Two capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.

Group Type: EXPERIMENTAL

STA-2

Intervention Type: DRUG

After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of STA-2 was:

STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state.

Placebo

Placebo capsule, containing non-active ingredients.

Two capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of Placebo was:

Placebo 250 mg capsule, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state.

Interventions

STA-2

After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of STA-2 was:

STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state.

Intervention Type: DRUG

Placebo

After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of Placebo was:

Placebo 250 mg capsule, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female aged > 20;

2. Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction ≥ 3 months before screening;

3. Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening (Day -7);

4. Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by >20% in total exercise time;

5. Female patient who was in the post-menopausal stage or of childbearing potential who:

• used adequate contraception since last menstruation and no plan for conception during the study;
• was non-lactating;
• had negative pregnancy test (urine) within 14 days prior to the study;

6. Able to provide written informed consent.

Exclusion Criteria

1. Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;

2. Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator;

3. Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);

4. Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;

5. Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) > 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine > 3 mg/dL);

6. Patients with severe gastrointestinal illness as judged by the investigator;

7. Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinphar Pharmaceutical Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chuen-Den Tseng, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology National Taiwan University Hospital

Locations

Chi Mei Medical Center

Tainan City, Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taipei, Taiwan

Countries

Taiwan

References

Unno T, Tago M, Suzuki Y, Nozawa A, Sagesaka YM, Kakuda T, Egawa K, Kondo K. Effect of tea catechins on postprandial plasma lipid responses in human subjects. Br J Nutr. 2005 Apr;93(4):543-7. doi: 10.1079/bjn20041379.

Reference Type: BACKGROUND

PMID: 15946418 (View on PubMed)

Maron DJ, Lu GP, Cai NS, Wu ZG, Li YH, Chen H, Zhu JQ, Jin XJ, Wouters BC, Zhao J. Cholesterol-lowering effect of a theaflavin-enriched green tea extract: a randomized controlled trial. Arch Intern Med. 2003 Jun 23;163(12):1448-53. doi: 10.1001/archinte.163.12.1448.

Reference Type: BACKGROUND

PMID: 12824094 (View on PubMed)

Other Identifiers

MCCD05014A

Identifier Type: -

Identifier Source: org_study_id