Phase II 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 Efficacy and Safety of STA-2 in Patients With Chronic Stable Angina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484912
• Other study ID #: MCCD05014A
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2007
• Last updated: December 1, 2011
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: December 2011
• 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 objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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).

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:
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Sinphar Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Exercise Time	Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.	baseline (visit 2) and week 6 (visit 5)	No
Secondary	Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).	Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.	baseline (visit 2) through week 6 (visit 5)	No
Secondary	Change in Consumption of Short-acting Nitrates	The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.	from baseline (visit 2) through week 6 (visit 5)	No
Secondary	Change in Rate-pressure Product	Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.	baseline (visit 2) to week 6 (visit 5)	No
Secondary	Change in Pharmacological Parameters	The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.	baseline (visit 2) to week 6 (visit 5)	No
Secondary	Consumption of Short-acting Nitrates		The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.	No