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

Erectile Dysfunction Clinical Trial

Official title:

Cardiovascular Safety Evaluation in Patients With Coronary Artery Disease During Physical Effort After Use Lodenafil Carbonate

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00817830
• Other study ID #: CRIST001
• Status: Withdrawn
• Phase: Phase 4
• First received: December 5, 2008
• Last updated: July 15, 2015
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: June 2011
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronaropathy
• Coronary Artery Disease
• Erectile Dysfunction

Intervention

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.

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Cristália Produtos Químicos Farmacêuticos Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy.		july 2009	Yes