A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization

Last updated: July 1, 2014
Sponsor: Merck KGaA, Darmstadt, Germany
Overall Status: Trial Not Available

Phase

4

Condition

Coronary Artery Disease

Cardiac Disease

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01185015
200101-500
  • Ages 18-70
  • All Genders

Study 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. The primary objective of this study is to demonstrate that orally administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent angina subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 priorcoronary 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 inthis clinical study during the study

  • Subjects should have an ability to give written informed consent

Exclusion

Exclusion Criteria:

  • 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 mmHgor 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 theupper limit of normal as determined by local clinical laboratory

  • Glaucoma

  • Concomitant medication such as Trimetazidine, Sulphonylurea, PDE-5 inhibitor such assildenafil, 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 presentstudy

Study Design

Study Start date:
January 01, 2011
Estimated Completion Date: