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

This study has suspended participant recruitment.
(The company decided to suspended the study because the investigational product will change.)
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01210365
First received: August 9, 2010
Last updated: June 25, 2013
Last verified: September 2010
  Purpose

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®)


Condition Intervention Phase
Congestive Heart Failure
Drug: Diurisa®
Drug: Lasix ®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

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) [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: January 2011
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: furosemide (40 mg) +amiloride (10 mg)
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®
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.
Active Comparator: Lasix ®
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 ®
One group of patients will receive furosemide 40mg .The patient will swallow the tablet in whole form on an empty stomach with some liquid.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210365

Locations
Brazil
Centro de Estudos de Diabetes e Hipertensão
Fortaleza, Ceará, Brazil
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
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01210365     History of Changes
Other Study ID Numbers: EF083
Study First Received: August 9, 2010
Last Updated: June 25, 2013
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Eurofarma Laboratorios S.A.:
CHF functional class II
Patients with CHF
Patients with CHF functional class II (NYHA) of any etiology

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Amiloride
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing
Cardiovascular Agents
Therapeutic Uses
Sodium Potassium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014