Congestive Heart FailurePhase 3NCT01210365
Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema
A Phase 3 study testing Diurisa® and Lasix ® in people with Congestive Heart Failure, run by Eurofarma Laboratorios S.A. at 4 sites in Brazil.
Trial summary
The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Diurisa® and Lasix ®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesBrazil
- Study dates
- 1 Jan 2011to Mar 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Must be able to follow instructions and attend study visits.
- Diagnosis of CHF functional class II (NYHA) without prior use of diuretics
- Women of childbearing potential who are using a reliable contraceptive method, as assessed by the principal investigator
Who cannot join
- Any clinically significant, serious or severe medical condition (e.g., Thyroid, renal or liver disorder, Chronic Obstructive Pulmonary Disease, etc.)
- History of acute myocardial infarction (within 6 months) or decompensated coronary artery disease
- Pulmonary hypertension - PASP > 45 mmHg
- Fasting blood glucose above 150 mg/dl
- Psychiatric or neurological disorders
- A condition that, according to Principal Investigator's opinion, may interfere with the optimal study participation or which may put the patient at special risk.
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- Participation in any other investigational study within 12 months before signing the ICF.
- Known medical history of allergy, hypersensitivity or intolerance to any of the components of the drugs to be used in this study.
- Any medical treatment that is unrelated to the study and scheduled to the clinical trial period, except for non-serious well-controlled comorbidities which are already being followed up medically.
- Another drug scheduled to be initiated after study entry.
- Obesity - BMI > 30 kg/m2
- Pregnancy and lactation
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Centro de Estudos de Diabetes e Hipertensão
Fortaleza, Ceará
Hospital dos Servidores do estado - Rio de Janeiro
Rio de Janeiro
Casa de Saúde Santa Marcelina
São Paulo
SITCOR Assistência Médica Integrada
São Paulo
About this study
Official title: Safety and Efficacy of the Combination of Furosemide 40 mg + Amiloride Hydrochloride 10 mg in the Reduction of Edema of Cardiac Origin in Patients With Congestive Heart Failure Functional Class II (NYHA)
The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)
Read the detailed description
General Purpose
- To comparatively evaluate the tolerability and efficacy of a fixed combination of furosemide (40 mg) and amiloride (10 mg) compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA)
Specific Purposes
- To evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)
- To evaluate the efficacy of the fixed combination of furosemide and amiloride in reducing edema of the LLLL, as compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA).
- Conditions
- Congestive Heart Failure
- Being tested
- Diurisa®, Lasix ®
- Keywords
- CHF functional class II, Patients with CHF, Patients with CHF functional class II (NYHA) of any etiology
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diurisa®Drug
Furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow onde tablet per day in whole form on an empty stomach with some liquid during 4 weeks.
Lasix ®Drug
One group of patients will receive furosemide 40mg .The patient will swallow the tablet in whole form on an empty stomach with some liquid.
| Study group | Role | What they receive |
|---|---|---|
| furosemide (40 mg) +amiloride (10 mg) | Experimental | One group of patients will receive furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow the tablet in whole form on an empty stomach with some liquid. Receives: Drug: Diurisa® |
| Lasix ® | Active comparator | One group of patients will receive Lasix® (furosemide 40 mg). For treatment, the patient will swallow the tablet in whole form on an empty stomach with some liquid. Receives: Drug: Lasix ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)
General physical examination and measure of potassium level in blood will be used for measuring the improvement of CHF symptoms and decrease in peripheral edema. The exams will be performed before the enrollment in the clinical study and every 7 days. Patients who have potassium levels below normal (normal K+ ≥ 3.5 mEq/l) after visit 2 may receive oral replacement, at the investigator's discretion, pursuant to the study site routine. The final evaluation will be performed 42 days after the inclusion of the last patient.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study start1 Jan 2011
- Primary completion1 Mar 2013
- Study completionMar 2013
Why it stopped: EF decided suspended the study because the investigational product was changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juliano N Cardoso, Principal investigator, Casa de Saúde santa MarcelinaRafael S Silva, Principal investigator, SITCOR - Assistência Médica IntegradaLuiz Maurino, Principal investigator, Hospital dos Servidores do Estado - Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210365
- Sponsor's protocol ID
- EF083
- Status last verified
- May 2022
- First submitted
- 9 Aug 2010
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Combination of Furosemide 40 mg + Amiloride Hydrochloride 10 mg in the Reduction of Edema of Cardiac Origin in Patients With Congestive Heart Failure Functional Class II (NYHA)
- ClinicalTrials.gov ID
- NCT01210365
- Acronym / sponsor ID
- EF083
- Conditions
- Congestive Heart Failure
- Keywords
- CHF functional class II, Patients with CHF, Patients with CHF functional class II (NYHA) of any etiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: EF decided suspended the study because the investigational product was changed.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Sep 2010 (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 study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)
Detailed description
General Purpose
- To comparatively evaluate the tolerability and efficacy of a fixed combination of furosemide (40 mg) and amiloride (10 mg) compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA)
Specific Purposes
- To evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)
- To evaluate the efficacy of the fixed combination of furosemide and amiloride in reducing edema of the LLLL, as compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| furosemide (40 mg) +amiloride (10 mg) | Experimental | Drug: Diurisa®One group of patients will receive furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow the tablet in whole form on an empty stomach with some liquid. |
| Lasix ® | Active comparator | Drug: Lasix ®One group of patients will receive Lasix® (furosemide 40 mg). For treatment, the patient will swallow the tablet in whole form on an empty stomach with some liquid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years old
- Must be able to follow instructions and attend study visits.
- Diagnosis of CHF functional class II (NYHA) without prior use of diuretics
- Women of childbearing potential who are using a reliable contraceptive method, as assessed by the principal investigator
Key exclusion criteria (12 listed)
- Any clinically significant, serious or severe medical condition (e.g., Thyroid, renal or liver disorder, Chronic Obstructive Pulmonary Disease, etc.)
- History of acute myocardial infarction (within 6 months) or decompensated coronary artery disease
- Pulmonary hypertension - PASP > 45 mmHg
- Fasting blood glucose above 150 mg/dl
- Psychiatric or neurological disorders
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 |
|---|---|---|
| Diurisa®Furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow onde tablet per day in whole form on an empty stomach with some liquid during 4 weeks. | Drug | furosemide (40 mg) +amiloride (10 mg) |
| Lasix ®One group of patients will receive furosemide 40mg .The patient will swallow the tablet in whole form on an empty stomach with some liquid. | Drug | Lasix ® |
Primary outcome
Evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)
Time frame: 5 months
General physical examination and measure of potassium level in blood will be used for measuring the improvement of CHF symptoms and decrease in peripheral edema. The exams will be performed before the enrollment in the clinical study and every 7 days. Patients who have potassium levels below normal (normal K+ ≥ 3.5 mEq/l) after visit 2 may receive oral replacement, at the investigator's discretion, pursuant to the study site routine. The final evaluation will be performed 42 days after the inclusion of the last patient.
Results and safety
The study was stopped early (reason given: EF decided suspended the study because the investigational product was changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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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.
Juliano N Cardoso principal investigator
Casa de Saúde santa Marcelina
Rafael S Silva principal investigator
SITCOR - Assistência Médica Integrada
Luiz Maurino principal investigator
Hospital dos Servidores do Estado - Rio de Janeiro
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diurisa® and Lasix ® in people with Congestive Heart Failure, run by Eurofarma Laboratorios S.A. at 4 sites 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: EF decided suspended the study because the investigational product was changed.). Results are not available in the source record.
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 the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA) (time frame: 5 months). 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 3 Jun 2022.