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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of STA-2 in Patients With Chronic Stable Angina

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.

Detailed Summary:

The primary objective of this study was to evaluate the efficacy of STA-2 in the management of chronic stable angina. The secondary objectives of this study were to evaluate the safety and pharmacological activities of STA-2 in the management of chronic stable angina. This was a multi-center, double-blind, randomized, parallel-group, placebo-controlled study of STA-2 in the management of chronic stable angina. The study period for each patient was approximately 7 weeks, during which the patient undergone one-week screening and washout period, followed by 6 weeks of treatment. Each patient was required to make a total of 5 visits. Primary Efficacy Endpoint: Change in total exercise time.

After washout, patients who met the inclusion and exclusion criteria were randomly assigned either to the treatment or control group. The respective regimens were:

Treatment group:

STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules ter in die (t.i.d.=three times daily) for 6 weeks, to be administered in a non-fasting state.

Control group:

Placebo 250 mg capsule, 2 capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.


Sponsor: Sinphar Pharmaceutical Co., Ltd

Current Primary Outcome: Change in Total Exercise Time [ Time Frame: baseline (visit 2) and week 6 (visit 5) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT). [ Time Frame: baseline (visit 2) through week 6 (visit 5) ]
    Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.
  • Change in Consumption of Short-acting Nitrates [ Time Frame: from baseline (visit 2) through week 6 (visit 5) ]
    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.
  • Change in Rate-pressure Product [ Time Frame: baseline (visit 2) to week 6 (visit 5) ]
    Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.
  • Change in Pharmacological Parameters [ Time Frame: baseline (visit 2) to week 6 (visit 5) ]
    The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.
  • Consumption of Short-acting Nitrates [ Time Frame: 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. ]


Original Secondary Outcome: Same as current

Information By: Sinphar Pharmaceutical Co., Ltd

Dates:
Date Received: May 9, 2007
Date Started: May 2007
Date Completion:
Last Updated: December 1, 2011
Last Verified: December 2011