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EF decided suspended the study because the investigational product was changed.
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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®)
General Purpose
1. 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliano N Cardoso | Casa de Saúde santa Marcelina | Principal Investigator |
| Rafael S Silva | SITCOR - Assistência Médica Integrada | Principal Investigator |
| Luiz Maurino | Hospital dos Servidores do Estado - Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Estudos de Diabetes e Hipertensão | Fortaleza | Ceará | Brazil | |||
| Hospital dos Servidores do estado - Rio de Janeiro |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| 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. |
|
| Rio de Janeiro |
| Brazil |
| Casa de Saúde Santa Marcelina | São Paulo | Brazil |
| SITCOR Assistência Médica Integrada | São Paulo | Brazil |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |