Cardiovascular Safety Study of Lodenafil Carbonate in Patients With Coronaropathy During Physical Effort
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|ClinicalTrials.gov Identifier: NCT00817830|
Recruitment Status : Withdrawn (Difficulty in patient recruitment)
First Posted : January 7, 2009
Last Update Posted : July 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Coronaropathy||Drug: lodenafil carbonate||Phase 4|
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 addition, ED can be an early manifestation of cardiovascular diseases.
Among the iPDE5 existing in the Brazilian market there is a new molecule which called lodenafil carbonate. It was recently approve and release for use in Brazil, and has similar effectiveness and adverse reactions comparing with other drugs from the same family.
The molecule was evaluated with respect to possible changes in heart rate, blood pressure and QT interval, and the results point out excellent cardiovascular safety profile.
There is a corelated incidence between patients with coronary artery disease and erectile dysfunction. Although patients with stable angina and, under appropriate clinical treatment did not show increase in cardiovascular risks during sexual intercourse, the increased incidence of erectile dysfunction in this population determines a specific group of patients with high potential for use iPDE5.
Therefore it is essential that any new phosphodiesterase 5 inhibitors should be evaluated in patients with coronary artery disease, especially in heart rate, during physical effort.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Cardiovascular Safety Evaluation in Patients With Coronary Artery Disease During Physical Effort After Use Lodenafil Carbonate|
|Study Start Date :||November 2008|
|Primary Completion Date :||May 2009|
|Study Completion Date :||October 2009|
Experimental: lodenafil carbonate
Evaluate cardiovascular safety of lodenafil carbonate in patients with coronary artery disease undergoing physical effort, before and after using lodenafil carbonate.
Drug: lodenafil carbonate
Patients will do a cardiopulmonary exercise test after placebo administration. Seven days later, a new cardiopulmonary test should be done using lodenafil carbonate, 80mg, orally.
Other Name: Helleva
- Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy. [ Time Frame: july 2009 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817830
|Irmandade da Santa Casa de Misericórdia de São Paulo|
|São Paulo, Brazil|
|Principal Investigator:||Roberto Franken, Doctor||Irmandade da Santa Casa de Misericórdia de São Paulo|