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

NCT00817830 | Withdrawn Phase 4 DMC

• 1 other identifier: CRIST001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction; Coronaropathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  july 2009

Study Arms (1)

lodenafil carbonate

EXPERIMENTAL

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

Drug: lodenafil carbonate

Interventions

lodenafil carbonate DRUG

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.

Also known as: Helleva

lodenafil carbonate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.: lead

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Erectile Dysfunction; Arrhythmias, Cardiac

Interventions

lodenafil carbonate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberto Franken, Doctor

  Irmandade da Santa Casa de Misericórdia de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: January 7, 2009
• Study Start: November 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 16, 2015

Record last verified: 2011-06

Locations

BR (1)