Phase III-B, open randomized study to evaluate the coronary vasodilator effect of a generic or reference propatylnitrate formulation administrated in sublingual route during coronariography

Completed

• Conditions: coronariography to investigate a coronary disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12608000546358
• Lead Sponsor: Eurofarma Laboratorios Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

subject who was clinical indicated to investigate coronary disease;
subject who had not used a nitrate formulation or a calcium channel antagonist 12 hours before coronariography

Exclusion Criteria

Acute miocardial infarction in less than 7 days; uncontrolled heart failure; cardiogenic arrest or haemodinamics instability; left coronary branch lesion >50%, non protected; left ventricular ejection fraction <30%; previous diagnosis of anterior decendent artery or cincurnflex occlusion; previous angioplasty with or without stent on the proximal third of the anterior decendent artery or on the circunflex; renal failure with creatinine >1,8mg/dl or patient dojng peritoneal dyalises or hemodyalisis

Study & Design

• Study Type: Interventional
• Study Design: Not specified