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

NCT01210365 | Terminated Phase 3 DMC

• 1 other identifier: EF083
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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®)

Conditions

Congestive Heart Failure

Keywords

CHF functional class II; Patients with CHF; Patients with CHF functional class II (NYHA) of any etiology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Drug: Lasix ®

Interventions

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.

furosemide (40 mg) +amiloride (10 mg)

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.

Lasix ®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (4)

Centro de Estudos de Diabetes e Hipertensão

Fortaleza, Ceará, Brazil

Location

Hospital dos Servidores do estado - Rio de Janeiro

Rio de Janeiro, Brazil

Location

Casa de Saúde Santa Marcelina

São Paulo, Brazil

Location

SITCOR Assistência Médica Integrada

São Paulo, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: September 28, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

BR (4)