- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01239511
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Kaohsiung, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Tainan, Taiwan
- Chi Mei Medical Center
-
Taipei, Taiwan
- National Taiwan University Hospital
-
Taipei, Taiwan
- Taipei Veterans General Hospital
-
Taipei, Taiwan
- Taipei Medical University-Shuang Ho Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo group
placebo capsule 2# t.i.d./day
|
2 capsules t.i.d., after meal
|
EXPERIMENTAL: Treatment Group A
150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
|
2 capsules t.i.d., after meal
|
EXPERIMENTAL: Treatment Group B
300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
|
2 capsules t.i.d., after meal
|
EXPERIMENTAL: Treatment Group C
450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
|
2 capsules t.i.d., after meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Exercise Time (Seconds)
Time Frame: 6 weeks after the first exercise tolerance testing is conducted
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Time to Onset of Angina From Baseline to the Final Visit
Time Frame: 6 weeks
|
6 weeks
|
Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit
Time Frame: 6 weeks
|
6 weeks
|
Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit
Time Frame: 6 weeks
|
6 weeks
|
Changes in Angina Frequency in Subject's Diary From Baseline to All Visits
Time Frame: 6 weeks
|
6 weeks
|
Change in Consumption of Short-acting Nitrates From Baseline to All Visits
Time Frame: 6 weeks
|
6 weeks
|
Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits
Time Frame: 6 weeks
|
6 weeks
|
Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits
Time Frame: 6 weeks
|
6 weeks
|
Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCCD09004A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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