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NCT01200836 · ClinicalTrials.gov registry record
Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
A clinical trial of Healthy Volunteers and Statins, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT01200836: Completed study of Healthy Volunteers and Statins, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01200836 is a study of Healthy Volunteers and Statins that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 20 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01200836, a study of Healthy Volunteers and Statins, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 the immune system and reduce inflammation, but the reason for this effect is unclear. Researchers are interested in testing the effect of rosuvastatin on the immune systems of healthy volunteers with good cholesterol levels. Objectives: \- To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers. Eligibility: \- Healthy individuals at least 18 years of age who have an acceptable blood level of LDL cholesterol (below 160). Design: * Participants will be screened with a medical history and physical examination, as well as blood tests to check general health, cholesterol levels, liver function, and the C-reactive protein (which responds to inflammation). * Participants will not be permitted to take most prescription and over-the-counter medications that affect the immune system, including antihistamines and certain pain relievers. For 1 week before the study, participants will have a wash-out period without any of these medications. * Participants will take rosuvastatin daily for 4 weeks, always in the evening (to ensure consistent blood sample results). * Participants will provide blood samples at the following time points: (1) immediately before the start of the rosuvastatin treatment, (2) after 2 weeks of treatment, (3) after 4 weeks of treatment, and (4) 2 weeks after the end of treatment.
Primary Outcome
An understanding of the mechanism by which statins effect the immune system may help us better define the patient population that might benefit from such therapy and potentially develop drugs that act more selectively and potently on the relevant immunologic pathway(s). We will also address the potential antithrombotic activity of statins.This study has been slow to recruit healthy subjects with elevated CRP, often because subjects with elevated CRP had mild abnormalities on a detailed history a
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-07-01 |
| Est. Completion | 2018-10-04 |
What the finished NCT01200836 record still lists
NCT01200836 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 0 interventions.
NCT01200836 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01200836 about?
NCT01200836 is a clinical study titled "Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol". 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 the immune system and reduce inflammation, but the reason for this effect is unclear. Researchers are...
What is the current status of trial NCT01200836?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2010-07-01. Estimated completion is 2018-10-04.
What conditions does trial NCT01200836 study?
This clinical trial studies the following conditions: Healthy Volunteers, Statins, Immune Modulation.
Who is sponsoring clinical trial NCT01200836?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01200836 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01200836's enrollment target sits among peer trials
20 222nd of 283 higher than 59 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
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