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Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

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ClinicalTrials.gov Identifier: NCT02152579
Recruitment Status : Unknown
Verified May 2014 by Laboratórios Baldacci S.A.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Laboratórios Baldacci S.A

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

Condition or disease Intervention/treatment Phase
Stable Angina Drug: Isosorbide-5-mononitrate Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

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




Primary Outcome Measures :
  1. Absolute number of episodes of angina [ Time Frame: 15 days ]
    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


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 15 days ]
    The secondary endpoints to be used are the other parameters supplied by the diary (incidence and intensity of Adverse Events).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152579


Contacts
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Contact: Rodrigo G Modolo, MD 55 19 3305 7391 rodrigo_modolo@yahoo.com.br
Contact: Carlos Sverdloff, MSc 19 98121 8440 carsver@atcgen.com.br

Locations
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Brazil
Clinicordis Not yet recruiting
Campinas, SP, Brazil, 13076 628
Contact: Rodrigo G Modolo, MD    55 19 3232 8524    rodrigo_modolo@yahoo.com.br   
Sponsors and Collaborators
Laboratórios Baldacci S.A
Investigators
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Principal Investigator: Rodrigo G Modolo, MD ATCGen

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Responsible Party: Laboratórios Baldacci S.A
ClinicalTrials.gov Identifier: NCT02152579     History of Changes
Other Study ID Numbers: ATC 001/14
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Keywords provided by Laboratórios Baldacci S.A:
Stable Angina
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action