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

NCT01484912 | Completed Phase 2 Results

• 1 other identifier: MCCD05014A
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Stable Angina

Keywords

Green tea polyphenols; Chronic Stable Angina

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).

  baseline (visit 2) through week 6 (visit 5)

• Change in Consumption of Short-acting Nitrates

  from baseline (visit 2) through week 6 (visit 5)

• Change in Rate-pressure Product

  baseline (visit 2) to week 6 (visit 5)

• Change in Pharmacological Parameters

  baseline (visit 2) to week 6 (visit 5)

• 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.

Study Arms (2)

STA-2

EXPERIMENTAL

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.

Drug: STA-2

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

STA-2 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.

STA-2

Placebo 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.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged \> 20;
• 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;
• 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);
• 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;
• 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;
• Able to provide written informed consent.

You may not qualify if:

• Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
• 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;
• Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);
• Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;
• 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);
• Patients with severe gastrointestinal illness as judged by the investigator;
• Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).

Sponsors & Collaborators

• Sinphar Pharmaceutical Co., Ltd: lead

Study Sites (3)

Chi Mei Medical Center

Tainan, Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taipei, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 15946418 BACKGROUND

• 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.

  PMID: 12824094 BACKGROUND

MeSH Terms

Conditions

Angina, Stable

Interventions

STA 2

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Justine Tang
• Organization: Sinphar Pharmaceutical Co., Ltd. Taiwan

justine@sinphar.com.tw

Study Officials

• Chuen-Den Tseng, MD, Ph.D

  Department of Cardiology National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2007
• First Posted: December 2, 2011
• Study Start: May 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 6, 2011
• Results First Posted: December 2, 2011

Record last verified: 2011-12

Locations

TW (3)