Chronic Stable Angina PectorisPhase 4NCT02315976
Acute Episodes in Chronic Stable Angina: Assessment of the Use of the Coronary Vasodilator Propatyl Nitrate.
A Phase 4 study testing Propatyl Nitrate in people with Chronic Stable Angina Pectoris, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.
Trial summary
This is an open, self-paired study of 200 patients with heart failure who have a diagnosis of chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate (10mg) . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00 PM. Read more about this study
- Who is it for?
- Ages 50 to 68 years
- Conditions the study is for
- Chronic Stable Angina Pectoris
- What is being tested?
- Propatyl Nitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Dec 2015
- Phase
- Phase 4
- 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 50 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic stable angina pectoris
- Female subjects post-menopausal or not pregnant and using of contraceptives
- Signature of Informed consent document
Who cannot join
- Pregnant women or nursing patients , women of childbearing age
- Hypersensitivity or intolerance to any component of the study drug
- Angina pectoris Class IV, according to the Canadian Society of Cardiology
- Clinical diagnosis of severe anemia , glaucoma, head trauma , increased intracranial pressure, cerebral hemorrhage, acute myocardial infarction, congestive heart failure, aortic valve disease
- Recent infarction (within the last 3 months)
- Recent history (within the last 6 months)of angioplasty
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- Use of these medicines within 7 days screening : sildenafil citrate and other inhibitors of phosphodiesterase-5 , adrenergic substances
- Significant alteration of any laboratory test (> 20% above or below the normal range )
- Gastric or intestinal ulcer or intestinal
- Asthma or chronic rhinitis
- Any other condition which in the opinion of the investigator, shall exclude the study of the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Avaliação de episódios Agudos na Angina Pectoris crônica estável: Abordagem clínico-laboratorial do Uso do Vasodilatador Coronariano Propatilnitrato.
This is an open, self-paired study of 200 patients with heart failure who have a diagnosis of chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate (10mg) . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00 PM. The study will include three visits the patient to the study center: Pretreatment / Assessment 1, Assessment 2 after 15 days of treatment, and the Assessment 3 after 30 days of treatment. At each visit, data will be collected on the medical history, physical examination and vital signs, and evaluation of episodes of angina pectoris, as well as the laboratory evaluation of adverse events and the use of concomitant medications.
- Conditions
- Chronic Stable Angina Pectoris
- Being tested
- Propatyl Nitrate
- Keywords
- chronic stable angina pectoris, propatyl nitrate, Seattle Angina Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propatyl NitrateDrug
Propatyl nitrate 10mg administered orally, three times daily
| Study group | Role | What they receive |
|---|---|---|
| Propatyl nitrate | Experimental | Patients treated with propatyl nitrate 10mg thrice daily Receives: Drug: Propatyl Nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of angina episodes
Number of angina episodes per patient during the 30 day treatment period
Measured: 30-day treatment period
Secondary outcomes (5)
Pain intensity
Percentage of patients with moderate (50-69mm) to severe (>70mm) pain (100mm visual analog pain scale)
Measured: 30-day treatment period
Episode duration
Number of angina episodes lasting two or more minutes
Measured: 30-day treatment period
Adverse Event - occurence
Number of patients presenting adverse events
Measured: 30-day treatment period
Seattle Angina Questionnaire (SAQ) scales score improvements
Improvement greater than or equal to 30% in SAQ scales scores of physical limitation, anginal stability, treatment satisfaction, and quality of life.
Measured: 30-day treatment period
Seattle Angina Questionnaire (SAQ) Score increase >30%
Percentage of patients with Seattle Angina Questionnaire score improvement greater than or equal to 30%
Measured: 30-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable Angina PectorisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Educacional Serra dos Órgãos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315976
- Sponsor's protocol ID
- APPN 01-01-13
- Status last verified
- Oct 2017
- First submitted
- 29 Nov 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avaliação de episódios Agudos na Angina Pectoris crônica estável: Abordagem clínico-laboratorial do Uso do Vasodilatador Coronariano Propatilnitrato.
- ClinicalTrials.gov ID
- NCT02315976
- Acronym / sponsor ID
- APPN 01-01-13
- Conditions
- Chronic Stable Angina Pectoris
- Keywords
- chronic stable angina pectoris, propatyl nitrate, Seattle Angina Questionnaire
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fundação Educacional Serra dos ÓrgãosUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Dec 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.
This is an open, self-paired study of 200 patients with heart failure who have a diagnosis of chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate (10mg) . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00 PM. The study will include three visits the patient to the study center: Pretreatment / Assessment 1, Assessment 2 after 15 days of treatment, and the Assessment 3 after 30 days of treatment. At each visit, data will be collected on the medical history, physical examination and vital signs, and evaluation of episodes of angina pectoris, as well as the laboratory evaluation of adverse events and the use of concomitant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propatyl nitrate | Experimental | Drug: Propatyl NitratePatients treated with propatyl nitrate 10mg thrice daily |
Who may qualify
- Ages
- 50 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of chronic stable angina pectoris
- Female subjects post-menopausal or not pregnant and using of contraceptives
- Signature of Informed consent document
Key exclusion criteria (11 listed)
- Pregnant women or nursing patients , women of childbearing age
- Hypersensitivity or intolerance to any component of the study drug
- Angina pectoris Class IV, according to the Canadian Society of Cardiology
- Clinical diagnosis of severe anemia , glaucoma, head trauma , increased intracranial pressure, cerebral hemorrhage, acute myocardial infarction, congestive heart failure, aortic valve disease
- Recent infarction (within the last 3 months)
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 |
|---|---|---|
| Propatyl NitratePropatyl nitrate 10mg administered orally, three times daily | Drug | Propatyl nitrate |
Primary outcome
Number of angina episodes
Time frame: 30-day treatment period
Number of angina episodes per patient during the 30 day treatment period
5 secondary outcomes
Pain intensity
Time frame: 30-day treatment period
Episode duration
Time frame: 30-day treatment period
Adverse Event - occurence
Time frame: 30-day treatment period
Seattle Angina Questionnaire (SAQ) scales score improvements
Time frame: 30-day treatment period
Seattle Angina Questionnaire (SAQ) Score increase >30%
Time frame: 30-day treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propatyl Nitrate in people with Chronic Stable Angina Pectoris, run by Fundação Educacional Serra dos Órgãos 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 26 Oct 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of angina episodes (time frame: 30-day treatment period). 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 26 Oct 2017.