Stable AnginaPhase 3NCT02152579
Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci
A Phase 3 study testing Isosorbide-5-mononitrate in people with Stable Angina, run by Laboratórios Baldacci S.A at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stable Angina
- What is being tested?
- Isosorbide-5-mononitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinicordis
Campinas, São Paulo, 13076 628
Rodrigo G Modolo, MD, 55 19 3232 8524, rodrigo_modolo@yahoo.com.br
About this study
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
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
Read the 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).
- Conditions
- Stable Angina
- Being tested
- Isosorbide-5-mononitrate
- Keywords
- Stable Angina
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide-5-mononitrateDrug
Also called Monocordil
Patients will receive 20mg monocordil tablets (Baldacci Laboratories).
| Study group | Role | What they receive |
|---|---|---|
| Isosorbide-5-mononitrate, tablet | Experimental | Single treatment arm. Receives: Drug: Isosorbide-5-mononitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Secondary outcomes (1)
Adverse events
The secondary endpoints to be used are the other parameters supplied by the diary (incidence and intensity of Adverse Events).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratórios Baldacci S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodrigo G Modolo, MD, Principal investigator, ATCGen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152579
- Sponsor's protocol ID
- ATC 001/14
- Status last verified
- May 2014
- First submitted
- 29 May 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02152579
- Acronym / sponsor ID
- ATC 001/14
- Conditions
- Stable Angina
- Keywords
- Stable Angina
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Laboratórios Baldacci S.AIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isosorbide-5-mononitrate, tablet | Experimental | Drug: Isosorbide-5-mononitrateSingle treatment arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isosorbide-5-mononitrateAlso: MonocordilPatients will receive 20mg monocordil tablets (Baldacci Laboratories). | Drug | Isosorbide-5-mononitrate, tablet |
Primary outcome
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
1 secondary outcome
Adverse events
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo G Modolo, MD principal investigator
ATCGen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isosorbide-5-mononitrate in people with Stable Angina, run by Laboratórios Baldacci S.A at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo G Modolo, MD (55 19 3305 7391, rodrigo_modolo@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute number of episodes of angina (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.