Status:
WITHDRAWN
A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Angina Pectoris
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The multi-centric, open label, single arm and self controlled study is planned to assess the efficacy of orally administered Sigmart in subjects with recurrent angina after coronary revascularization....
Eligibility Criteria
Inclusion
- Subjects should be 18\~70 years old, male or female
- Subjects should have a history of coronary revascularization at least 6 months ago
- Subjects should present with typical angina or similar to the chest pain before prior coronary revascularization for at least 1 month
- Subjects should be relieved from anginal attacks with short-acting NTG
- Subjects should have the ability to withhold medication which cannot be concomitant in this clinical study during the study
- Subjects should have an ability to give written informed consent
Exclusion
- Unstable angina
- Left main coronary artery disease
- Aortic stenosis
- Obstructive hypertrophic cardiomyopathy
- Subjects with hypertension (SBP\>170 mmHg or DBP\>100 mmHg) or hypotension (SBP\<90 mmHg or DBP\<60 mmHg)
- Postural hypotension (drop in systolic blood pressure \>20% after 2 minute standing),
- Congestive heart failure (NYHA class III - IV)
- Ejection fraction (EF)\<45% by Echocardiography
- Peripheral arterial obstructive disease or other diseases limiting exercise testing
- Arrhythmias requiring active treatment
- Gastro-intestinal ulcer
- Liver dysfunction (defined as ALT or bilirubin\>1.5×upper limit of normal value)
- Significant renal impairment, such as serum creatinine greater than 1.5 folds the upper limit of normal as determined by local clinical laboratory
- Glaucoma
- Concomitant medication such as Trimetazidine, Sulphonylurea, PDE-5 inhibitor such as sildenafil, Chinese traditional medicine for treatment of angina pectoris
- Known intolerance to nitrates
- Known allergic to nicotinic acid
- Pregnant or lactating women
- Any other contraindications mentioned in the SPC
- Participation in another clinical study within the last 3 months
- Legal incapacity or limited legal capacity
- Any other subjects assessed by the investigator as being unsuitable for the present study
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01185015
Start Date
January 1 2011
Last Update
July 2 2014
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