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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propatyl nitrate | Experimental | Patients treated with propatyl nitrate 10mg thrice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propatyl Nitrate | Drug | Propatyl nitrate 10mg administered orally, three times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of angina episodes | Number of angina episodes per patient during the 30 day treatment period | 30-day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Percentage of patients with moderate (50-69mm) to severe (>70mm) pain (100mm visual analog pain scale) | 30-day treatment period |
| Episode duration | Number of angina episodes lasting two or more minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIFESO | Teresópolis | Rio de Janeiro | 25964-004 | Brazil |
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| ID | Term |
|---|---|
| C026352 | propatyl nitrate |
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| 30-day treatment period |
| Adverse Event - occurence | Number of patients presenting adverse events | 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. | 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% | 30-day treatment period |