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

Primary Purpose

Congestive Heart Failure

Status

Terminated

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Diurisa®

Lasix ®

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring CHF functional class II, Patients with CHF, Patients with CHF functional class II (NYHA) of any etiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Centro de Estudos de Diabetes e Hipertensão
Hospital dos Servidores do estado - Rio de Janeiro
Casa de Saúde Santa Marcelina
SITCOR Assistência Médica Integrada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

furosemide (40 mg) +amiloride (10 mg)

Lasix ®

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01210365

First Posted

August 9, 2010

Last Updated

May 31, 2022

Sponsor

Eurofarma Laboratorios S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01210365

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

EF decided suspended the study because the investigational product was changed.

Study Start Date

January 1, 2011 (Actual)

Primary Completion Date

March 1, 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 patients with HF functional class II (NYHA) Specific Purposes 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) 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congestive Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

furosemide (40 mg) +amiloride (10 mg)

Arm Type

Experimental

Arm Description

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.

Arm Title

Lasix ®

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Diurisa®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lasix ®

Intervention Description

One group of patients will receive furosemide 40mg .The patient will swallow the tablet in whole form on an empty stomach with some liquid.

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juliano N Cardoso

Organizational Affiliation

Casa de Saúde santa Marcelina

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rafael S Silva

Organizational Affiliation

SITCOR - Assistência Médica Integrada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luiz Maurino

Organizational Affiliation

Hospital dos Servidores do Estado - Rio de Janeiro

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro de Estudos de Diabetes e Hipertensão

City

Fortaleza

State/Province

Ceará

Country

Brazil

Facility Name

Hospital dos Servidores do estado - Rio de Janeiro

City

Rio de Janeiro

Country

Brazil

Facility Name

Casa de Saúde Santa Marcelina

City

São Paulo

Country

Brazil

Facility Name

SITCOR Assistência Médica Integrada

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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