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Sponsored by: |
Rovi Pharmaceuticals Laboratories |
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Information provided by: | Rovi Pharmaceuticals Laboratories |
ClinicalTrials.gov Identifier: | NCT00413088 |
Open pharmacokinetic study with 5 parallel groups and two treatment phases (bemiparin 3,500 IU multiple dose and bemiparin 115 IU/kg single dose). The bemiparin pharmacokinetic profile will be assessed by measuring its effects on the coagulation cascade. Plasma anti-Xa activity (measured using chromogenic amidolytic assay) in IU per milliliter will be the primary endpoint to assess the pharmacokinetic profile of bemiparin.
Condition | Intervention | Phase |
---|---|---|
Renal Insufficiency |
Drug: bemiparin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Clinical Trial to Assess Bemiparin Pharmacokinetics at Therapeutic (115 IU/kg) and Prophylactic Doses (3500 IU) Administered Subcutaneously in Single or Multiple Doses in Renal Insufficiency and in the Elderly |
Estimated Enrollment: | 60 |
Study Start Date: | March 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Non-elderly healthy volunteers (Group I):
Patients with renal insufficiency (Groups II, III and IV):
Male or female subjects aged between 18 and 65 years, who will be assigned to one of the following groups according to renal function:
Elderly healthy volunteers (Group V):
Exclusion Criteria:
Non-elderly healthy volunteers (Group I):
Patients with renal insufficiency or elderly healthy volunteers (Groups II, III, IV, V):
Contact: Rovi, Medical Department | +34.91.375.62.30 | departamento.medico@rovi.es |
Spain | |
Hospital de la Santa Creu i Sant Pau and Fundació Puigvert | Recruiting |
Barcelona, Spain, 08008 | |
Contact: Barbanoj Manuel mbarbanoj@santpau.es | |
Principal Investigator: Manuel Barbanoj |
Principal Investigator: | Manuel Barbanoj, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Responsible Party: | Rovi Pharmaceuticals Laboratories ( Medical Deparment ) |
Study ID Numbers: | ROV-BEM-2005-01 |
Study First Received: | December 14, 2006 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00413088 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
renal insufficency low molecular weight heparin pharmacokinetics elderly |
Body Weight Renal Insufficiency Urologic Diseases Heparin, Low-Molecular-Weight |
Kidney Diseases Heparin Calcium heparin |
Renal Insufficiency Urologic Diseases Kidney Diseases |