Status:
COMPLETED
Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy Volunteers
Statins
Eligibility:
All Genders
18-99 years
Brief Summary
Background: \- The drug rosuvastatin (also called Crestor) is used to lower cholesterol levels in people with elevated cholesterol levels. Recent studies have suggested that rosuvastatin may affect t...
Detailed Description
Statins are drugs that inhibit cholesterol synthesis and are used extensively for primary and secondary prevention of heart disease. Their benefit to patients with heart diseases appears to exceed tha...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy volunteer (health status confirmed by brief History and Physical Exam and routine blood work as determined by the screening protocol)
- Age greater than or equal to18 years of age
- LDL \< 160 mg/dL
- Ten subjects must have hsCRP \< 2mg/L, and ten subjects must have hsCRP greater than or equal to 2 mg/L
- Subjects with psoriasis that are otherwise healthy, who have not received any systemic imunosuppression in the past 6 months
- Subjects with fasting glucose \< 125 mg/dL
- EXCLUSION CRITERIA:
- Female subjects may not be pregnant or lactating due to minor side effects of use of statins in a non-benefit study.
- Abnormal LFT s, i.e. AST \> 34 U/L; ALT \> 41 U/L; T. Bilirubin \>1.0 mg/dL; Alkaline Phosphatasse \> 116 U/L.
- Other contraindication to statins (i.e. inadequately treated hypothyroidism, renal impairment, liver disease, elevated transaminases, diabetes mellitus or hypersensitivity to a statin)
- Subjects unable to comprehend the investigational nature of the procedure or unable or unwilling to sign the consent.
- Statin usage within the last six months prior to enrollment.
- Diabetes mellitus
- Subjects not willing to participate in the gene expression analysis and whole genome expression and polymorphisms studies portion of this protocol.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 4 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01200836
Start Date
July 1 2010
End Date
October 4 2018
Last Update
October 9 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892