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

July 15, 2015 updated by: Cristália Produtos Químicos Farmacêuticos Ltda.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Helleva

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristália Produtos Químicos Farmacêuticos Ltda.

Investigators

  • Principal Investigator: Roberto Franken, Doctor, Irmandade Da Santa Casa De Misericordia De Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

October 1, 2009

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRIST001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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