- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01660295
Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
August 5, 2012 updated by: Novartis Pharmaceuticals
An Open-label, Single Center, Parallel-group Study to Compare the Single- and Repeated-dose Pharmacokinetics of Stepwise Increasing Doses of Subcutaneous Certoparin (3000 IU o.d., 3000 IU b.i.d., 8000 IU o.d., and 8000 IU b.i.d.) in Subjects With Severe Renal Insufficiency and Healthy Subjects
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ady E. u.
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H-8230 Balatonfüred, Ady E. u., Hungary, 12
- DRC Drug Research Center Ltd., H-8230 Balatonfüred
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Healthy subjects OR
- Subjects with severe renal insufficiency
Exclusion criteria:
- Hypersensitivity to study medication
- Genetic abnormality or disease of clotting system
- Prior major surgery or bleeding
- Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 subcutaneous injection once daily
Other Names:
Certoparin 8,000 IU subcutaneous injection twice a day
Other Names:
|
Experimental: 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 subcutaneous injection once daily
Other Names:
Certoparin 8,000 IU subcutaneous injection twice a day
Other Names:
Certoparin 3,000 IU subcutaneous injection twice a day
Other Names:
Certoparin 8,000 IU subcutaneous injection once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma aXa-Profile: C0
Time Frame: 5 days
|
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
|
5 days
|
Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)
Time Frame: 5 days
|
Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d.
IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d.
IU aXa in CON-subjects.
|
5 days
|
Plasma aXa-Profile: Cmax
Time Frame: 5 days
|
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel.
|
5 days
|
Plasma aXa-Profile: AUC
Time Frame: 5 days
|
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
December 20, 2011
First Submitted That Met QC Criteria
August 5, 2012
First Posted (Estimate)
August 8, 2012
Study Record Updates
Last Update Posted (Estimate)
August 8, 2012
Last Update Submitted That Met QC Criteria
August 5, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Dopamine Agonists
- Dopamine Agents
- Anticoagulants
- Vasoconstrictor Agents
- Heparin, Low-Molecular-Weight
- Certoparin
- Dihydroergotamine
Other Study ID Numbers
- CMEX839BDE07
- 2011-001930-40 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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