Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema
Information source: Eurofarma Laboratorios S.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congestive Heart Failure
Intervention: Diurisa® (Drug); Lasix ® (Drug)
Phase: Phase 3
Status: Suspended
Sponsored by: Eurofarma Laboratorios S.A. Official(s) and/or principal investigator(s): Juliano N Cardoso, Principal Investigator, Affiliation: Casa de Saúde Santa Marcelina Rafael S Silva, Principal Investigator, Affiliation: SITCOR - Assistência Médica Integrada Luiz Maurino, Principal Investigator, Affiliation: Hospital dos Servidores do Estado - Rio de Janeiro
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®)
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
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
patients with HF functional class II (NYHA)
Specific Purposes
1. 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)
2. 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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Being over 18 years old
2. Must be able to follow instructions and attend study visits.
3. Diagnosis of CHF functional class II (NYHA) without prior use of diuretics
4. Women of childbearing potential who are using a reliable contraceptive method, as
assessed by the principal investigator
Exclusion Criteria:
1. Any clinically significant, serious or severe medical condition (e. g., Thyroid, renal
or liver disorder, Chronic Obstructive Pulmonary Disease, etc.)
2. History of acute myocardial infarction (within 6 months) or decompensated coronary
artery disease
3. Pulmonary hypertension - PASP > 45 mmHg
4. Fasting blood glucose above 150 mg/dl
5. Psychiatric or neurological disorders
6. 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.
7. Participation in any other investigational study within 12 months before signing the
ICF.
8. Known medical history of allergy, hypersensitivity or intolerance to any of the
components of the drugs to be used in this study.
9. 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.
10. Another drug scheduled to be initiated after study entry.
11. Obesity - BMI > 30 kg/m2
12. Pregnancy and lactation
Locations and Contacts
Hospital dos Servidores do estado - Rio de Janeiro, Rio de Janeiro, Brazil
Casa de Saúde Santa Marcelina, São Paulo, Brazil
SITCOR Assistência Médica Integrada, São Paulo, Brazil
Centro de Estudos de Diabetes e Hipertensão, Fortaleza, Ceará, Brazil
Additional Information
Starting date: January 2011
Last updated: June 25, 2013
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