Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride
Transcrição
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.
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