Status:
COMPLETED
Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin
Lead Sponsor:
University of Oslo School of Pharmacy
Collaborating Sponsors:
The Hospital of Vestfold
Conditions:
Morbid Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Altered bioavailability of drugs will potentially affect both drug efficacy as well as safety. In patients subjected to bariatric surgery due to morbid obesity the gastro intestinal tract is considera...
Detailed Description
The primary objective of the study is to compare the effect of gastric bypass and BPD+DS operations on atorvastatin bioavailability. Secondary objectives are to determine the relative change in atorv...
Eligibility Criteria
Inclusion
- Scheduled for bariatric surgery.
- 18 years of age or older.
- Ongoing treatment with statin.
- Able and willing to donate GI-tract and liver biopsies.
- Signed informed consent.
Exclusion
- Concomitant treatment with drugs and/or other factors that may influence atorvastatin pharmacokinetics
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00331565
Start Date
August 1 2006
End Date
December 1 2010
Last Update
December 3 2014
Active Locations (1)
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1
Hospital in Vestfold
Tønsberg, Norway, 3103