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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01239511
First received: November 10, 2010
Last updated: August 13, 2014
Last verified: August 2014

November 10, 2010
August 13, 2014
November 2010
April 2012   (final data collection date for primary outcome measure)
Change in Total Exercise Time (Seconds) [ Time Frame: 6 weeks after the first exercise tolerance testing is conducted ] [ Designated as safety issue: No ]
the time difference of total exercise time from V2 to V5 compare to placebo
Change in total exercise time [ Time Frame: 6 weeks after the first exercise tolerance testing is conducted ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01239511 on ClinicalTrials.gov Archive Site
  • Change in Time to Onset of Angina From Baseline to the Final Visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Changes in Angina Frequency in Subject's Diary From Baseline to All Visits [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in Consumption of Short-acting Nitrates From Baseline to All Visits [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in time to onset of angina from baseline to the final visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Changes in time to 1mm ST-segment depression during ETT from baseline to final visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Changes in time to maximum ST-segment depression during ETT from baseline to the final visit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase IIb Study of STA-2 in Patients With Chronic Stable Angina
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Dose-Response and Safety of STA-2 in Patients With Chronic Stable Angina

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Stable Angina
Drug: green tea polyphenols (STA-2)
2 capsules t.i.d., after meal
  • Placebo Comparator: Placebo group
    placebo capsule 2# t.i.d./day
    Intervention: Drug: green tea polyphenols (STA-2)
  • Experimental: Treatment Group A
    150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
    Intervention: Drug: green tea polyphenols (STA-2)
  • Experimental: Treatment Group B
    300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
    Intervention: Drug: green tea polyphenols (STA-2)
  • Experimental: Treatment Group C
    450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
    Intervention: Drug: green tea polyphenols (STA-2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01239511
MCCD09004A
Yes
Sinphar Pharmaceutical Co., Ltd
Sinphar Pharmaceutical Co., Ltd
Not Provided
Principal Investigator: Chuen-Den Tseng, MD, Ph.D Department of Cardiology National Taiwan University Hospital
Sinphar Pharmaceutical Co., Ltd
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP