Erectile DysfunctionPhase 4NCT00817830
Cardiovascular Safety Study of Lodenafil Carbonate in Patients With Coronaropathy During Physical Effort
A Phase 4 study testing lodenafil carbonate in people with Erectile Dysfunction and Coronaropathy, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction, Coronaropathy
- What is being tested?
- lodenafil carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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%.
Who cannot join
- 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;
Show all 16Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo
About this study
Official title: 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.
Read the 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.
- Conditions
- Erectile Dysfunction, Coronaropathy
- Being tested
- lodenafil carbonate
- Keywords
- Coronaropathy, lodenafil carbonate, Erectile dysfunction, Treatment, QT interval, Phosphodiesterase inhibitors, Cardiac arrhythmia, Effort testPhosphodiesterase 5 inhibitors, Cardiovascular test
- Medical subject headings
- Erectile Dysfunction, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lodenafil carbonateDrug
Also called Helleva
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.
| Study group | Role | What they receive |
|---|---|---|
| lodenafil carbonate | Experimental | Evaluate cardiovascular safety of lodenafil carbonate in patients with coronary artery disease undergoing physical effort, before and after using lodenafil carbonate. Receives: Drug: lodenafil carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy.
Measured: july 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionOct 2009
Why it stopped: Difficulty in patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roberto Franken, Doctor, Principal investigator, Irmandade da Santa Casa de Misericórdia de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817830
- Sponsor's protocol ID
- CRIST001
- Status last verified
- Jun 2011
- First submitted
- 5 Dec 2008
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Safety Evaluation in Patients With Coronary Artery Disease During Physical Effort After Use Lodenafil Carbonate
- ClinicalTrials.gov ID
- NCT00817830
- Acronym / sponsor ID
- CRIST001
- Conditions
- Erectile Dysfunction, Coronaropathy
- Keywords
- Coronaropathy, lodenafil carbonate, Erectile dysfunction, Treatment, QT interval, Phosphodiesterase inhibitors, Cardiac arrhythmia, Effort testPhosphodiesterase 5 inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2009
- Study completion
- Oct 2009
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lodenafil carbonate | Experimental | Drug: lodenafil carbonateEvaluate cardiovascular safety of lodenafil carbonate in patients with coronary artery disease undergoing physical effort, before and after using lodenafil carbonate. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lodenafil carbonateAlso: HellevaPatients will do a cardiopulmonary exercise test after placebo administration. Seven days later, a new cardiopulmonary test should be done using lodenafil carbonate, 80mg, orally. | Drug | lodenafil carbonate |
Primary outcome
Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy.
Time frame: july 2009
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Franken, Doctor principal investigator
Irmandade da Santa Casa de Misericórdia de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lodenafil carbonate in people with Erectile Dysfunction and Coronaropathy, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate changes in effort test showing the safety of lodenafil carbonate in patients with coronaropathy. (time frame: july 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.