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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 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.

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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.

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-07-01
Est. Completion 2018-10-04

What the Registry Record Tells You About NCT01200836

The ClinicalTrials.gov registry entry for NCT01200836 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 0 interventions.

NCT01200836 reports 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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