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

Primary Purpose

Erectile Dysfunction, Coronaropathy

Status
Withdrawn
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
lodenafil carbonate
Sponsored by
Cristália Produtos Químicos Farmacêuticos Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Coronaropathy, lodenafil carbonate, Erectile dysfunction, Treatment, QT interval, Phosphodiesterase inhibitors, Cardiac arrhythmia, Effort testPhosphodiesterase 5 inhibitors, Cardiovascular test

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Irmandade da Santa Casa de Misericórdia de São Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lodenafil carbonate

Arm Description

Evaluate cardiovascular safety of lodenafil carbonate in patients with coronary artery disease undergoing physical effort, before and after using lodenafil carbonate.

Outcomes

Primary Outcome Measures

Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2008
Last Updated
July 15, 2015
Sponsor
Cristália Produtos Químicos Farmacêuticos Ltda.
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1. Study Identification

Unique Protocol Identification Number
NCT00817830
Brief Title
Cardiovascular Safety Study of Lodenafil Carbonate in Patients With Coronaropathy During Physical Effort
Official Title
Cardiovascular Safety Evaluation in Patients With Coronary Artery Disease During Physical Effort After Use Lodenafil Carbonate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in patient recruitment
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (undefined)
Study Completion Date
October 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cristália Produtos Químicos Farmacêuticos Ltda.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Coronaropathy
Keywords
Coronaropathy, lodenafil carbonate, Erectile dysfunction, Treatment, QT interval, Phosphodiesterase inhibitors, Cardiac arrhythmia, Effort testPhosphodiesterase 5 inhibitors, Cardiovascular test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lodenafil carbonate
Arm Type
Experimental
Arm Description
Evaluate cardiovascular safety of lodenafil carbonate in patients with coronary artery disease undergoing physical effort, before and after using lodenafil carbonate.
Intervention Type
Drug
Intervention Name(s)
lodenafil carbonate
Other Intervention Name(s)
Helleva
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy.
Time Frame
july 2009

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Franken, Doctor
Organizational Affiliation
Irmandade da Santa Casa de Misericórdia de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

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

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