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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

Tracking Information
First Submitted Date  ICMJE May 29, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date June 2, 2014
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stable Angina
Intervention  ICMJE Drug: Isosorbide-5-mononitrate
Patients will receive 20mg monocordil tablets (Baldacci Laboratories).
Other Name: Monocordil
Study Arms  ICMJE Experimental: Isosorbide-5-mononitrate, tablet
Single treatment arm.
Intervention: Drug: Isosorbide-5-mononitrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 30, 2014)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152579
Other Study ID Numbers  ICMJE ATC 001/14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratórios Baldacci S.A
Study Sponsor  ICMJE Laboratórios Baldacci S.A
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo G Modolo, MD ATCGen
PRS Account Laboratórios Baldacci S.A
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP