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NCT04964544

Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

A Phase III, 6-Month Self-selection and Actual Use Study for Rx-to-OTC Switch of Rosuvastatin 5 mg Once-daily in Combination With a Web App
AstraZeneca·Phase 3·ClinicalTrials.gov·combination productRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
High Cholesterol
Drug/Device/Intervention
5 mg rosuvastatin calcium with a Web App (combination product)
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
AstraZeneca
Location
Indianapolis, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Jul 08, 2021
End date
Feb 20, 2023
Enrollment
1220 participants
Primary outcome

Percentage of participants with an Overall Correct (correct + mitigated) Initial TASS Outcome at the initial self-selection,Percentage of participants with an Overall Correct (correct + mitigated) Final Use Outcome at the final use assessment,Percent change from baseline in verified LDL-C to Visit 2

Summary

The purpose of this AUS is to evaluate the extent to which participants can safely and
 effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to
 the label.

ICD-10 classifications
Cholesterolosis of gallbladderPure hypercholesterolaemiaOther disorders of lipoprotein metabolismDisorder of lipoprotein metabolism, unspecifiedDisorders of lipoprotein metabolism and other lipidaemias
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04964544
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04964544 through Pure Global AI's free database. This Phase 3 trial is sponsored by AstraZeneca and is currently Recruiting. The study focuses on High Cholesterol. Target enrollment is 1220 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.