Overview

This trial is active, not recruiting.

Condition chronic stable angina pectoris
Treatment propatyl nitrate
Phase phase 4
Sponsor Fundação Educacional Serra dos Órgãos
Start date April 2014
End date December 2014
Trial size 200 participants
Trial identifier NCT02315976, APPN 01-01-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients treated with propatyl nitrate 10mg thrice daily
propatyl nitrate
Propatyl nitrate 10mg administered orally, three times daily

Primary Outcomes

Measure
Number of angina episodes
time frame: 30-day treatment period

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 50 years up to 68 years old.

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.

Additional Information

Official title Avaliação de episódios Agudos na Angina Pectoris crônica estável: Abordagem clínico-laboratorial do Uso do Vasodilatador Coronariano Propatilnitrato.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Fundação Educacional Serra dos Órgãos.