Trial | NCT01210365  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    27
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®)
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).
Study Started
Jan 01
2011
Primary Completion
Mar 01
2013
Study Completion
Mar 31
2013
Last Update
Jun 03
2022

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.

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.

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.

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.

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
No Results Posted