Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

Open Monocentric Clinical Study for the Evaluation of Efficacy and Safety of 20 mg Monocordil Tablets Manufactured by Laboratórios Baldacci in Patients With Stable Angina

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

Study Overview

• Status: Unknown
• Conditions: Stable Angina
• Intervention / Treatment: Drug: Isosorbide-5-mononitrate

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).

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rodrigo G Modolo, MD; Phone Number: 55 19 3305 7391; Email: rodrigo_modolo@yahoo.com.br
• Study Contact Backup: Name: Carlos Sverdloff, MSc; Phone Number: 19 98121 8440; Email: carsver@atcgen.com.br

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil, 13076 628
      • Clinicordis
      • Contact: Rodrigo G Modolo, MD; Phone Number: 55 19 3232 8524; Email: rodrigo_modolo@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isosorbide-5-mononitrate, tablet; Single treatment arm.	Drug: Isosorbide-5-mononitrate; Patients will receive 20mg monocordil tablets (Baldacci Laboratories).; Other Names: Monocordil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute number of episodes of angina	The absolute parameter of incidence of improvement will be used as primary endpoint, being considered as improvement the reduction in the number of events in 15 days, after the beginning of the intake of the study medication, and the intensity of the angina crisis	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	The secondary endpoints to be used are the other parameters supplied by the diary (incidence and intensity of Adverse Events).	15 days

Collaborators and Investigators

• Sponsor: Laboratórios Baldacci S.A
• Investigators: Principal Investigator: Rodrigo G Modolo, MD, ATCGen

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: May 29, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): June 2, 2014
• Last Update Submitted That Met QC Criteria: May 30, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Stable Angina
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Nitric Oxide Donors; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
• Other Study ID Numbers: ATC 001/14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No