Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride

Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride

Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride
10mg to Reduct Edema
Status: Suspended
Study Phase: Phase 3
Start Date: January 2011 | Completion Date: February 2013
Condition(s): Congestive Heart Failure
Full Title of Study
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)
Overview
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
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).
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose:
Treatment
Investigator Details
Lead Sponsor: Eurofarma Laboratorios S.A.
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
Trial Location Details
Facility: Centro de Estudos de Diabetes e Hipertensão Fortaleza, Brazil
Facility: Hospital dos Servidores do estado - Rio de Janeiro Rio de Janeiro, Brazil
Facility: Casa de Saúde Santa Marcelina São Paulo, Brazil
Facility: SITCOR Assistência Médica Integrada São Paulo, Brazil
Interventions
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.
Information Source
ID Number: EF083
NCT Identifier: NCT01210365
Health Authority: Array
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01210365
by this site. Please see the full source link above for retrieving further details from the government database.