Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
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ClinicalTrials.gov Identifier: NCT01346215
Verified April 2011 by Laboratório Químico Farmacêutico Bergamo Ltda.. Recruitment status was: Not yet recruiting
The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients research that agree to participate in the study and sign the informed consent form;
Patients aged over 18 years, both sexes, regardless of color or social class;
Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
Patients with laboratory results within specified acceptance criteria.
Patients who are taking part or took part in another clinical investigational study within 12 months;
Hypersensitivity to heparin sodium and/or benzyl alcohol;
History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
Severe liver disease;
Patients in cancer treatment;
Pregnant and lactating women;
Use of glucocorticoids over physiological dose;
Use of other anticoagulants;
Patients undergoing any surgery performed less than 15 days;
History of non response or exacerbated response to heparin sodium;