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NCT02215174 · ClinicalTrials.gov registry record · Phase 1

Rosuvastatin Interethnic PK Study

A Phase 1 study, sponsored by University of California, San Francisco.

Terminated
Registry status
Phase 1
Development phase
21
Enrollment target

NCT02215174 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 21 participants.

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The verdict

NCT02215174, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.

TERMINATED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

Statins are the first-line and most commonly prescribed drugs for the prevention of cardiovascular diseases and stroke in the world. Our preliminary studies suggest that Caucasians might have a higher risk of developing potentially life-threatening drug-drug interactions than Asians when taking statins. Drug-drug interactions occur in the body when two or more drugs interact in a way that alters their effectiveness and/or toxicity. These interactions are becoming an increasingly severe problem with statin usage since patients at higher risk for cardiovascular diseases also take statins combined with many other drugs, such as antihypertensive and diabetic drugs. Our study is aimed at understanding the molecular factors and providing a sound basis for the interethnic dosage and response differences for statins. Drug-transporting proteins in intestine and liver tissues are responsible for taking up statins into the blood. It is hypothesized that there are interethnic function differences of these proteins and that they account for differences in statin blood levels between Caucasians and Asians and the frequency and/or severity of their respective drug-drug interactions. A clinical study will be conducted with Caucasian and Asian subjects undergoing gastric bypass surgery so excess intestine and liver tissue can be acquired as part of the standard procedure. Protein levels will be quantified in the tissues and correlate them with different statin blood levels.

Interventions

  • DRUG Rosuvastatin

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2015-02
Est. Completion 2018-12-06
Phase Phase 1

What the Registry Record Tells You About NCT02215174

The ClinicalTrials.gov registry entry for NCT02215174 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Rosuvastatin is the first listed.

NCT02215174 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02215174 about?

NCT02215174 is a clinical study titled "Rosuvastatin Interethnic PK Study". Statins are the first-line and most commonly prescribed drugs for the prevention of cardiovascular diseases and stroke in the world. Our preliminary studies suggest that Caucasians might have a higher risk of developing potentially life-threatening drug-drug interactions than Asians when taking stat...

What is the current status of trial NCT02215174?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2015-02. Estimated completion is 2018-12-06.

What interventions are being tested in trial NCT02215174?

The interventions under investigation include: Rosuvastatin (DRUG).

Who is sponsoring clinical trial NCT02215174?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.