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

NCT01239511 | Completed Phase 2 Results DMC

• 1 other identifier: MCCD09004A
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Stable Angina

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change in Time to Onset of Angina From Baseline to the Final Visit

  6 weeks

• Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit

  6 weeks

• Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit

  6 weeks

• Changes in Angina Frequency in Subject's Diary From Baseline to All Visits

  6 weeks

• Change in Consumption of Short-acting Nitrates From Baseline to All Visits

  6 weeks

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

placebo capsule 2# t.i.d./day

Drug: green tea polyphenols (STA-2)

Treatment Group A

EXPERIMENTAL

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)

Treatment Group B

EXPERIMENTAL

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)

Treatment Group C

EXPERIMENTAL

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)

Interventions

green tea polyphenols (STA-2) DRUG

2 capsules t.i.d., after meal

Placebo group; Treatment Group A; Treatment Group B; Treatment Group C

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 years;
• Subjects weight \> 50 kg
• subjects who had more than 50% coronary stenosis documented by catheterization or ever received coronary intervention;
• 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;
• The difference in exercise duration between screening (Visit 1) and baseline (Visit 2) do not exceed 20% of the longer test;
• Able to provide written informed consent.

You may not qualify if:

• Subjects with pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
• Subjects with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, subjects who need digoxin or digitalis;
• Subjects with any resting EKG abnormalities preventing the interpretation of ischemia as judged by the investigator;
• Subjects with COPD requiring bronchodilators;
• 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;
• Subjects with documented evidence of gastroduodenal ulcer disease, gastrointestinal bleeding or other gastrointestinal disease within the preceding 3 months as judged by investigator;
• 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;
• Subject with any conditions that could interfere the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stoke);
• Female subjects of childbearing potential who:
• are lactating;
• have positive pregnancy test (urine) at V1;
• Subject has received any investigational agent within 28 days prior to the first dose of investigational product;
• Subjects who have had administered STA-2 in prior clinical trial.

Sponsors & Collaborators

• Sinphar Pharmaceutical Co., Ltd: lead

Study Sites (5)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, Taiwan

Location

Chi Mei Medical Center

Tainan, Taiwan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Location

Taipei Medical University-Shuang Ho Hospital

Taipei, Taiwan, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

Tea; 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

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Melanie Huang
• Organization: Sinphar Pharmaceutical Co., Ltd.

wthuang@sinphar.com.tw

886-2-27603688

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: November 10, 2010
• First Posted: November 11, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 27, 2014
• Results First Posted: August 27, 2014

Record last verified: 2014-08

Locations

TW (5)