Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase III clinical study for the evaluation of clinic and cardiologic effects of isosorbide mononitrate from the incidence of events (angina episodes).

This is an open, comparative, monocentric trial. The hypothesis, regarding the number of angina episodes, to be tested are:

• H0: μD = 0 ot H0: μAfter = μBefore

• HA: μD ≠ 0 ot HA: μBefore ≠ μAfter

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratórios Baldacci S.A
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

Criteria

Inclusion Criteria:

• Capacity for understanding and agreement in signing the informed consent form

• Age 18 between 18 and 80 years old

• Have a diagnosis of stable angina, proved by ECG, test of physical effort or similar

• Not being under treatment with other nitrate for stable angina

• Medical indication for the use of isosorbide mononitrate (Monocordil)

Exclusion Criteria:

• Presence or serious comorbidities (under judgement of the investigator)

• Allergy to any of the component of the investigational product

• Pregnant female patients, brest feeding and/or in fertile condition who wish to get pregnant during the study and deny the use of contraceptives