Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

Laboratórios Baldacci

Status and phase

Unknown

Phase 3

Conditions

Stable Angina

Treatments

Drug: Isosorbide-5-mononitrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT02152579

ATC 001/14

Details and patient eligibility

About

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

Full description

Phase III study, monocentric, open, with a single treatment arm in patients with stable angina to evaluates efficacy and safety. The study will be sponsored by pelo Laboratórios Baldacci. All patients who participate in the study shall sign two copies of the informed consent form. The inclusion of patients is expected to last until 12 months from the approval of the Ethics Committee and ANVISA.

Follow up will last at least 2 weeks for each included patient. A total of 86 patients will be recruited for this study and all of them will initiate treatment with 20 mg monocordil tablets. After 2 consecutive weeks using the investigational product (+2 days), the patients will be evaluated again, particularly for the parameters under study, this is, quantity and severity of angina episodes and adverse events. The selected patients shall also be 18-80 years old of both genders, with proved diagnosis of stable angina through clinical exams such as ECG, physical effort tests or similar. Patients will receive 20mg monocordil tablets (Baldacci Laboratories).

The evaluations will take place in two opportunities: one at the visit of medical evaluation and recruitment in the study (along with the deliver of the study medication and a diary) and the second one after 2 weeks (+2 days) of use of 20mg monocordil tablets for medical evaluation and discharge of the study (return of the diary and medication accountability).

Enrollment

86 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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