Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Eurofarma Laboratorios S.A..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Eurofarma Laboratorios S.A.
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01210365
First received: August 9, 2010
Last updated: September 27, 2010
Last verified: September 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | February 2011 (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
- 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210365
Locations
| Brazil | |
| Centro de Estudos de Diabetes e Hipertensão | Not yet recruiting |
| Fortaleza, Ceará, Brazil | |
| Contact: Viviana 55 85 3105-8300 cedh@cedh.med.br | |
| Principal Investigator: Adriana Forti | |
| Hospital dos Servidores do estado - Rio de Janeiro | Not yet recruiting |
| Rio de Janeiro, Brazil | |
| Contact: Luiz Maurino 55 21 2518-2067 lmaurino@globo.com | |
| Principal Investigator: Luiz Maurino | |
| Casa de Saúde Santa Marcelina | Not yet recruiting |
| São Paulo, Brazil | |
| Contact: Juliano N Cardoso 55 11 2217-3766 cpchsm@santamarcelina.org | |
| Principal Investigator: Juliano N Cardoso | |
| SITCOR Assistência Médica Integrada | Not yet recruiting |
| São Paulo, Brazil | |
| Contact: Rafael S Silva 55 11 3661-1313 dr.rafaelsouza@ig.com.br | |
| Principal Investigator: Rafael S Silva | |
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: | Estela Maia Bellini Pannuti, Eurofarma Laboratórios Ltda. |
| ClinicalTrials.gov Identifier: | NCT01210365 History of Changes |
| Other Study ID Numbers: | EF083 |
| Study First Received: | August 9, 2010 |
| Last Updated: | September 27, 2010 |
| 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 Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Potassium Chloride Symporter Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013