A Phase 4 interventional study of Atorvastatin in Inflammation, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-15.
Sponsored by University of Florida · Phase 4, Interventional, and Screening
The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.
All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.
3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.
This study's enrollment of 108 is above the median of 50 across 2,491 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Exclusion Criteria:
80mg of atorvastatin given once daily for 16 weeks
Drug: Atorvastatin
atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Also known as: Lipitor
Mean Change in Level: Week 16-baseline in Ena-78
We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
Time frame: 16 weeks after baseline
University of Florida Clinical Research Center. Study started June 2004 and ended January 9, 2009.
| Milestone | Atorvastatin |
|---|---|
| Started | 108 |
| Completed | 81 |
| Not completed | 27 |
| Withdrew: Lost to follow-up | 27 |
We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
| pg/ml | Atorvastatin 80 MG/Day |
|---|---|
| Mean Change in Level: Week 16-baseline in Ena-78 | -111.2 ± 690.5 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atorvastatin | — | 0/108 (0%) | 14/108 (13%) |
| Event | Atorvastatin |
|---|---|
| Muscle achesMusculoskeletal and connective tissue disorders | 14/108 |
| HeadacheGeneral disorders | 12/108 |
| Age, Categorical(Participants) | Atorvastatin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 107 |
| >=65 years | 1 |
| Age Continuous(years) | Atorvastatin |
|---|---|
| Mean | 31.6 ± 12.6 |
| Sex: Female, Male(Participants) | Atorvastatin |
|---|---|
| Female | 66 |
| Male | 42 |
| Region of Enrollment(participants) | Atorvastatin |
|---|---|
| United States | 108 |
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atorvastatin