Chronic Stable Angina Pectoris
Conditions
Keywords
chronic stable angina pectoris, propatyl nitrate, Seattle Angina Questionnaire
Brief 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. 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.
Interventions
DRUGPropatyl Nitrate
Propatyl nitrate 10mg administered orally, three times daily
Sponsors
Fundação Educacional Serra dos Órgãos
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of chronic stable angina pectoris * Female subjects post-menopausal or not pregnant and using of contraceptives * Signature of Informed consent document
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of angina episodes | 30-day treatment period | Number of angina episodes per patient during the 30 day treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 30-day treatment period | Percentage of patients with moderate (50-69mm) to severe (\>70mm) pain (100mm visual analog pain scale) |
| Episode duration | 30-day treatment period | Number of angina episodes lasting two or more minutes |
| Adverse Event - occurence | 30-day treatment period | Number of patients presenting adverse events |
| Seattle Angina Questionnaire (SAQ) scales score improvements | 30-day treatment period | Improvement greater than or equal to 30% in SAQ scales scores of physical limitation, anginal stability, treatment satisfaction, and quality of life. |
| Seattle Angina Questionnaire (SAQ) Score increase >30% | 30-day treatment period | Percentage of patients with Seattle Angina Questionnaire score improvement greater than or equal to 30% |
Countries
Brazil
Outcome results
None listed