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

Last updated: May 31, 2022
Sponsor: Eurofarma Laboratorios S.A.
Overall Status: Terminated

Phase

3

Condition

Congestive Heart Failure

Heart Failure

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01210365
EF083
  • Ages > 18
  • All Genders

Study 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®)

Eligibility Criteria

Inclusion

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, asassessed by the principal investigator

Exclusion

Exclusion Criteria:

  1. Any clinically significant, serious or severe medical condition (e.g., Thyroid, renalor liver disorder, Chronic Obstructive Pulmonary Disease, etc.)
  2. History of acute myocardial infarction (within 6 months) or decompensated coronaryartery 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 withthe optimal study participation or which may put the patient at special risk.
  7. Participation in any other investigational study within 12 months before signing theICF.
  8. Known medical history of allergy, hypersensitivity or intolerance to any of thecomponents of the drugs to be used in this study.
  9. Any medical treatment that is unrelated to the study and scheduled to the clinicaltrial period, except for non-serious well-controlled comorbidities which are alreadybeing followed up medically.
  10. Another drug scheduled to be initiated after study entry.
  11. Obesity - BMI > 30 kg/m2
  12. Pregnancy and lactation

Study Design

Total Participants: 27
Study Start date:
January 01, 2011
Estimated Completion Date:
March 31, 2013

Study 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).

Connect with a study center

  • Centro de Estudos de Diabetes e Hipertensão

    Fortaleza, Ceará
    Brazil

    Site Not Available

  • Hospital dos Servidores do estado - Rio de Janeiro

    Rio de Janeiro,
    Brazil

    Site Not Available

  • SITCOR Assistência Médica Integrada

    São Paulo,
    Brazil

    Site Not Available

  • Casa de Saúde Santa Marcelina

    São Paulo,
    Brazil

    Site Not Available

  • SITCOR Assistência Médica Integrada

    São Paulo,
    Brazil

    Site Not Available

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