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
Results First Received: August 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Stable Angina
Intervention: Drug: green tea polyphenols (STA-2)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from Nov. 2010 through Apr. 2012. There are 5 study sites participated in this study, including National Taiwan University Hospita, Chi Mei Medical Center, Taipei Veterans General Hospital, Taipei Medical University-Shuang Ho Hospital and Kaohsiung Medical University Chung-Ho emorial Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In order to ensure the consistency, the difference of total exercise time between V1 and V2 should be less than 20%.

Reporting Groups
  Description
Placebo Group placebo capsule 2# t.i.d./day
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)

Participant Flow:   Overall Study
    Placebo Group     Treatment Group A     Treatment Group B     Treatment Group C  
STARTED     47     45     47     47  
COMPLETED     46     40     43     38  
NOT COMPLETED     1     5     4     9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For subjects without the primary efficacy variable due to early discontinuaton and those with protocol violation were excluded from the analysis group.

Reporting Groups
  Description
Placebo Group placebo capsule 2# t.i.d./day
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)
Total Total of all reporting groups

Baseline Measures
    Placebo Group     Treatment Group A     Treatment Group B     Treatment Group C     Total  
Number of Participants  
[units: participants]
  46     43     42     37     168  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     29     24     30     23     106  
>=65 years     17     19     12     14     62  
Age  
[units: years]
Mean ± Standard Deviation
  60.6  ± 0.76     62.1  ± 10.40     61.4  ± 10.57     59.6  ± 10.11     61.0  ± 10.43  
Gender  
[units: participants]
         
Female     9     7     8     4     28  
Male     37     36     34     33     140  
Region of Enrollment  
[units: participants]
         
Taiwan     46     43     42     37     168  



  Outcome Measures

1.  Primary:   Change in Total Exercise Time (Seconds)   [ Time Frame: 6 weeks after the first exercise tolerance testing is conducted ]

2.  Secondary:   Change in Time to Onset of Angina From Baseline to the Final Visit   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Angina Frequency in Subject's Diary From Baseline to All Visits   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change in Consumption of Short-acting Nitrates From Baseline to All Visits   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Melanie Huang
Organization: Sinphar Pharmaceutical Co., Ltd.
phone: 886-2-27603688 ext 2190
e-mail: wthuang@sinphar.com.tw


No publications provided


Responsible Party: Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01239511     History of Changes
Other Study ID Numbers: MCCD09004A
Study First Received: November 10, 2010
Results First Received: August 13, 2014
Last Updated: August 13, 2014
Health Authority: Taiwan: Department of Health
United States: Food and Drug Administration