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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00817830
Recruitment Status : Withdrawn (Difficulty in patient recruitment)
First Posted : January 7, 2009
Last Update Posted : July 16, 2015
Information provided by:
Cristália Produtos Químicos Farmacêuticos Ltda.

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.

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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

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

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

Information from the National Library of Medicine

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

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;

Information from the National Library of Medicine

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 identifier (NCT number): NCT00817830

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Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
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Principal Investigator: Roberto Franken, Doctor Irmandade da Santa Casa de Misericórdia de São Paulo
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Responsible Party: Dr. Jorge Barros Afiune, Cristália Pordutos Químicos Farmacêuticos Ltda Identifier: NCT00817830    
Other Study ID Numbers: CRIST001
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: June 2011
Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
lodenafil carbonate
Erectile dysfunction
QT interval
Phosphodiesterase inhibitors
Cardiac arrhythmia
Effort testPhosphodiesterase 5 inhibitors
Cardiovascular test
Additional relevant MeSH terms:
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Erectile Dysfunction
Coronary Artery Disease
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases