Cardiovascular Safety Study of Lodenafil Carbonate in Patients With Coronaropathy During Physical… (NCT00817830) | Clinical Trial Compass
WithdrawnPhase 4
Cardiovascular Safety Study of Lodenafil Carbonate in Patients With Coronaropathy During Physical Effort
Stopped: Difficulty in patient recruitment
Brazil0Started 2008-11
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy.