Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

NCT ID: NCT02152579

Last Updated: 2014-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-10-31

Brief 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

Detailed 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).

Conditions

Stable Angina

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Isosorbide-5-mononitrate, tablet

Single treatment arm.

Group Type: EXPERIMENTAL

Isosorbide-5-mononitrate

Intervention Type: DRUG

Patients will receive 20mg monocordil tablets (Baldacci Laboratories).

Interventions

Isosorbide-5-mononitrate

Patients will receive 20mg monocordil tablets (Baldacci Laboratories).

Intervention Type: DRUG

Other Intervention Names

Monocordil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratórios Baldacci S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodrigo G Modolo, MD

Role: PRINCIPAL_INVESTIGATOR

ATCGen

Locations

Clinicordis

Campinas, São Paulo, Brazil

Countries

Brazil

Central Contacts

Rodrigo G Modolo, MD

Role: CONTACT

rodrigo_modolo@yahoo.com.br

55 19 3305 7391

Carlos Sverdloff, MSc

Role: CONTACT

carsver@atcgen.com.br

19 98121 8440

Facility Contacts

Rodrigo G Modolo, MD

Role: primary

rodrigo_modolo@yahoo.com.br

55 19 3232 8524

Other Identifiers

ATC 001/14

Identifier Type: -

Identifier Source: org_study_id