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

• ClinicalTrials.gov Identifier: NCT00817830
• Recruitment Status: Withdrawn
• First Posted: January 7, 2009
• Last Update Posted: July 16, 2015
• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Information provided by: Cristália Produtos Químicos Farmacêuticos Ltda.

Study Description

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 respiratory components, with and without use of lodenafil carbonate 80mg.

Condition or disease	Intervention/treatment	Phase
Erectile Dysfunction; Coronaropathy	Drug: lodenafil carbonate	Phase 4

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 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy. [ Time Frame: july 2009 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

Brazil

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, Brazil

Sponsors and Collaborators

Cristália Produtos Químicos Farmacêuticos Ltda.

Investigators

• Principal Investigator: Roberto Franken, Doctor; Irmandade da Santa Casa de Misericórdia de São Paulo

More Information

• Responsible Party: Dr. Jorge Barros Afiune, Cristália Pordutos Químicos Farmacêuticos Ltda
• ClinicalTrials.gov Identifier: NCT00817830
• Other Study ID Numbers: CRIST001
• First Posted: January 7, 2009
• Last Update Posted: July 16, 2015
• Last Verified: June 2011

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Coronaropathy; lodenafil carbonate; Erectile dysfunction; Treatment; QT interval; Phosphodiesterase inhibitors; Cardiac arrhythmia; Effort testPhosphodiesterase 5 inhibitors; Cardiovascular test

Additional relevant MeSH terms:

Erectile Dysfunction; Coronary Artery Disease; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases