Acute Episodes in Chronic Stable Angina: Assessment of the Use of the Coronary Vasodilator Propatyl Nitrate.

Fundação Educacional Serra dos Órgãos

Status and phase: Completed; Phase 4

Conditions: Chronic Stable Angina Pectoris

Treatments: Drug: Propatyl Nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02315976

APPN 01-01-13

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 50 to 68 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Propatyl nitrate

Experimental group

Description:

Patients treated with propatyl nitrate 10mg thrice daily

Treatment:

Drug: Propatyl Nitrate