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Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

NCT02152579 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2014-06-02

No results posted yet for this study

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

Interventions

DRUG

Isosorbide-5-mononitrate

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

Sponsors & Collaborators

  • Laboratórios Baldacci S.A

    lead INDUSTRY

Principal Investigators

  • Rodrigo G Modolo, MD · ATCGen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-09-30
Completion
2014-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02152579 on ClinicalTrials.gov