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
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Isosorbide-5-mononitrate, tablet
Single treatment arm.
Patients will receive 20mg monocordil tablets (Baldacci Laboratories).
Other Name: Monocordil
- 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
- 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).
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
|Contact: Rodrigo G Modolo, MD||55 19 3305 firstname.lastname@example.org|
|Contact: Carlos Sverdloff, MSc||19 98121 email@example.com|
|Campinas, SP, Brazil, 13076 628|
|Contact: Rodrigo G Modolo, MD 55 19 3232 8524 firstname.lastname@example.org|
|Principal Investigator:||Rodrigo G Modolo, MD||ATCGen|