A Phase 3 interventional study of Isosorbide-5-mononitrate in Stable Angina, sponsored by Laboratórios Baldacci S.A. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-02.
Sponsored by Laboratórios Baldacci S.A · Phase 3, Interventional, and Treatment
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:
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).
519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.
This study's planned enrollment of 86 is below the median of 123 across 336 interventional studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →Laboratórios Baldacci S.A is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single treatment arm.
Drug: Isosorbide-5-mononitrate
Patients will receive 20mg monocordil tablets (Baldacci Laboratories).
Also known as: Monocordil
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
Time frame: 15 days
Adverse events
The secondary endpoints to be used are the other parameters supplied by the diary (incidence and intensity of Adverse Events).
Time frame: 15 days
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Laboratórios Baldacci S.A