Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01346215
Recruitment Status : Unknown
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
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;