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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01484912
• Date of registration: 09/05/2007
• Prospective Registration: No
• Primary sponsor: Sinphar Pharmaceutical Co., Ltd
• Public title: Phase II Study of STA-2 in Patients With Chronic Stable Angina
• Scientific title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of STA-2 in Patients With Chronic Stable Angina
• Date of first enrolment: May 2007
• Target sample size: 79
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01484912
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Chuen-Den Tseng, MD, Ph.D
• Affiliation: Department of Cardiology National Taiwan University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:

1. Male or female aged > 20;

2. Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or
who had catheterization-documented coronary artery disease or previous myocardial
infarction = 3 months before screening;

3. Patients who manifested positive ETT (exercise tolerance testing) (defined as
ST-segment depression = 1 mm compared with at rest, with or without limiting angina)
at screening (Day -7);

4. Patients who manifested positive ETT (exercise tolerance testing) (defined as
ST-segment depression = 1 mm compared with at rest, with or without limiting angina)
on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were
required not differ by >20% in total exercise time;

5. Female patient who was in the post-menopausal stage or of childbearing potential who:

- used adequate contraception since last menstruation and no plan for conception
during the study;

- was non-lactating;

- had negative pregnancy test (urine) within 14 days prior to the study;

6. Able to provide written informed consent.

Exclusion criteria:

1. Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable
angina or myocardial infarction within the preceding 3 months;

2. Patients with heart failure (New York Heart Association class III or IV), uncorrected
valvular or congenital heart disease, patients who needed digoxin, isosorbide
mononitrate, nitroglycerin sustained release preparation, theophylline, class I
antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the
investigator;

3. Patients with any EKG abnormalities preventing the interpretation of ischemia
(complete left bundle branch block);

4. Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;

5. Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine
transaminase (ALT) > 3X the upper limit of normal values), and/or renal failure
(defined as serum creatinine > 3 mg/dL);

6. Patients with severe gastrointestinal illness as judged by the investigator;

7. Patient with any conditions that interfered the performance of exercise tolerance test
as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Stable Angina

Intervention(s)

Drug: STA-2

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

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.]

Change in Pharmacological Parameters [Time Frame: baseline (visit 2) to week 6 (visit 5)]

Change in Consumption of Short-acting Nitrates [Time Frame: from baseline (visit 2) through week 6 (visit 5)]

Change in Rate-pressure Product [Time Frame: baseline (visit 2) to week 6 (visit 5)]

Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT). [Time Frame: baseline (visit 2) through week 6 (visit 5)]

Secondary ID(s)

MCCD05014A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/12/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01484912