Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
NCT ID: NCT01660295
Last Updated: 2012-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Certoparin control
Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
Certoparin 3,000 IU Once Daily
Certoparin 3,000 IU subcutaneous injection once daily
Certoparin 8,000 IU Twice a Day
Certoparin 8,000 IU subcutaneous injection twice a day
Certoparin Renal
Participants receive dose escalation upon medical criteria qualification at each period:
Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.
Certoparin 3,000 IU Once Daily
Certoparin 3,000 IU subcutaneous injection once daily
Certoparin 3,000 IU Twice a Day
Certoparin 3,000 IU subcutaneous injection twice a day
Certoparin 8,000 IU Once Daily
Certoparin 8,000 IU subcutaneous injection once daily
Certoparin 8,000 IU Twice a Day
Certoparin 8,000 IU subcutaneous injection twice a day
Interventions
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Certoparin 3,000 IU Once Daily
Certoparin 3,000 IU subcutaneous injection once daily
Certoparin 3,000 IU Twice a Day
Certoparin 3,000 IU subcutaneous injection twice a day
Certoparin 8,000 IU Once Daily
Certoparin 8,000 IU subcutaneous injection once daily
Certoparin 8,000 IU Twice a Day
Certoparin 8,000 IU subcutaneous injection twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with severe renal insufficiency
Exclusion Criteria
* Genetic abnormality or disease of clotting system
* Prior major surgery or bleeding
21 Years
60 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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DRC Drug Research Center Ltd., H-8230 Balatonfüred
H-8230 Balatonfüred, Ady E. U., Hungary
Countries
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Other Identifiers
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2011-001930-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CMEX839BDE07
Identifier Type: -
Identifier Source: org_study_id