Cardiovascular Safety Study of Lodenafil Carbonate in Patients With Coronaropathy During Physical Effort

• Status: Withdrawn
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the safety of lodenafil carbonate in patients with coronaropathy, evaluating the response of the body facing physical effort, including both heart and respiratory components, with and without use of lodenafil carbonate 80mg.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Criteria

Inclusion Criteria:

• Coronary artery disease with obstruction <70%, confirmed by prior catheterization, stable patient, and have already showed an acute event (unstable angina or myocardial infarction, according to the guidelines of the Brazilian Society of Cardiology) for at least 6 months;

• Age ≥ 18 and ≤ 60;

• Men;

• Stable for 6 months, regardless of previous myocardial infarction or revascularization;

• ejection fraction of doppler echocardiography ≥ 50%.

Exclusion Criteria:

• Use of nitrate;

• Use of bronchodilators;

• Smoking current period or in less than 6 months;

• Hemoglobin <10 g / dL;

• Systolic pressure> 160 mm Hg and <100 mmHg;

• Diastolic pressure> 110 mm Hg and <60 mmHg;

• Body mass index (BMI)> 30;

• Symptomatic peripheral artery disease;

• Event of angina or AMI, at any time, whether I've done some examination or not;

• Finger tip blood glucose < 70 and > 200mg/dL at the time of examination;

• Chest injury > 50%;

• Triple arterial injury with surgery indication;

• Moderate or severe chronic obstructive pulmonary disease (COPD) confirmed by spirometry;

• Pulmonary hypertension with pressure > 35mmHg confirmed by doppler echocardiography;

• Moderate or important aortic and/or mitral valvulopathy confirmed by doppler echocardiography;

• Changes in enzyme markers (Troponin I) after the first test;