Status:
TERMINATED
Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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®)
Detailed Description
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 pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01210365
Start Date
January 1 2011
End Date
March 1 2013
Last Update
June 3 2022
Active Locations (4)
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1
Centro de Estudos de Diabetes e Hipertensão
Fortaleza, Ceará, Brazil
2
Hospital dos Servidores do estado - Rio de Janeiro
Rio de Janeiro, Brazil
3
Casa de Saúde Santa Marcelina
São Paulo, Brazil
4
SITCOR Assistência Médica Integrada
São Paulo, Brazil