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

This study has been withdrawn prior to enrollment.
(Difficulty in patient recruitment)
Sponsor:
Information provided by:
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT00817830
First received: December 5, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Erectile Dysfunction
Coronaropathy
Drug: lodenafil carbonate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cardiovascular Safety Evaluation in Patients With Coronary Artery Disease During Physical Effort After Use Lodenafil Carbonate

Resource links provided by NLM:


Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

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

Estimated Enrollment: 20
Study Start Date: November 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817830

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

No publications provided

Responsible Party: Dr. Jorge Barros Afiune, Cristália Pordutos Químicos Farmacêuticos Ltda
ClinicalTrials.gov Identifier: NCT00817830     History of Changes
Other Study ID Numbers: CRIST001
Study First Received: December 5, 2008
Last Updated: June 6, 2011
Health Authority: Brazil: National Health Surveillance Agency

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:
Coronary Artery Disease
Erectile Dysfunction
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014