Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

NCT02152579 | Unknown Phase 3

• 1 other identifier: ATC 001/14
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Stable Angina

Keywords

Stable Angina

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  15 days

Study Arms (1)

Isosorbide-5-mononitrate, tablet

EXPERIMENTAL

Single treatment arm.

Drug: Isosorbide-5-mononitrate

Interventions

Isosorbide-5-mononitrate DRUG

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

Also known as: Monocordil

Isosorbide-5-mononitrate, tablet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratórios Baldacci S.A: lead

Study Sites (1)

Clinicordis

Campinas, São Paulo, 13076 628, Brazil

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

isosorbide-5-mononitrate

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo G Modolo, MD

  ATCGen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo G Modolo, MD

CONTACT

55 19 3305 7391; rodrigo_modolo@yahoo.com.br

Carlos Sverdloff, MSc

CONTACT

19 98121 8440; carsver@atcgen.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

BR (1)