Status:
WITHDRAWN
Cardiovascular Safety Study of Lodenafil Carbonate in Patients With Coronaropathy During Physical Effort
Lead Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Conditions:
Erectile Dysfunction
Coronaropathy
Eligibility:
MALE
18-60 years
Phase:
PHASE4
Brief 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 respirator...
Detailed Description
Phosphodiesterase 5 inhibitors (iPDE5) are effective drugs to treat erectile dysfunction (ED). ED is linked to several factors, like advanced age and diabetes as predominant in its incidence. In addi...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00817830
Start Date
November 1 2008
End Date
October 1 2009
Last Update
July 16 2015
Active Locations (1)
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1
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil