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Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema

Information source: Eurofarma Laboratorios S.A.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congestive Heart Failure

Intervention: Diurisa® (Drug); Lasix ® (Drug)

Phase: Phase 3

Status: Not yet recruiting

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; Not yet recruiting
Luiz Maurino, Phone: 55 21 2518-2067, Email: lmaurino@globo.com
Luiz Maurino, Principal Investigator

Casa de Saúde Santa Marcelina, São Paulo, Brazil; Not yet recruiting
Juliano N Cardoso, Phone: 55 11 2217-3766, Email: cpchsm@santamarcelina.org
Juliano N Cardoso, Principal Investigator

SITCOR Assistência Médica Integrada, São Paulo, Brazil; Not yet recruiting
Rafael S Silva, Phone: 55 11 3661-1313, Email: dr.rafaelsouza@ig.com.br
Rafael S Silva, Principal Investigator

Centro de Estudos de Diabetes e Hipertensão, Fortaleza, Ceará, Brazil; Not yet recruiting
Viviana, Phone: 55 85 3105-8300, Email: cedh@cedh.med.br
Adriana Forti, Principal Investigator

Additional Information

Starting date: January 2011
Last updated: September 27, 2010

Page last updated: February 07, 2013

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