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

NCT02315976 | Completed Phase 4

• 1 other identifier: APPN 01-01-13
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stable Angina Pectoris

Keywords

chronic stable angina pectoris; propatyl nitrate; Seattle Angina Questionnaire

Outcome Measures

Primary Outcomes (1)

• Number of angina episodes

  Number of angina episodes per patient during the 30 day treatment period

  30-day treatment period

Secondary Outcomes (5)

• Pain intensity

  30-day treatment period

• Episode duration

  30-day treatment period

• Adverse Event - occurence

  30-day treatment period

• Seattle Angina Questionnaire (SAQ) scales score improvements

  30-day treatment period

• Seattle Angina Questionnaire (SAQ) Score increase >30%

  30-day treatment period

Study Arms (1)

Propatyl nitrate

EXPERIMENTAL

Patients treated with propatyl nitrate 10mg thrice daily

Drug: Propatyl Nitrate

Interventions

Propatyl Nitrate DRUG

Propatyl nitrate 10mg administered orally, three times daily

Propatyl nitrate

Eligibility Criteria

• Age: 50 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of chronic stable angina pectoris
• Female subjects post-menopausal or not pregnant and using of contraceptives
• Signature of Informed consent document

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundação Educacional Serra dos Órgãos: lead

Study Sites (1)

UNIFESO

Teresópolis, Rio de Janeiro, 25964-004, Brazil

Location

MeSH Terms

Interventions

propatyl nitrate

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: November 29, 2014
• First Posted: December 12, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

BR (1)