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Technology-Assisted Cholesterol Trial in Consumers (TACTiC) - Trial NCT04964544

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.

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NCT04964544
Phase 3
Recruiting
combination product
Trial Details
ClinicalTrials.gov โ€ข NCT04964544
View on ClinicalTrials.gov
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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

Study Focus

High Cholesterol

5 mg rosuvastatin calcium with a Web App (combination product)

Interventional

combination product

Sponsor & Location

AstraZeneca

Indianapolis, United States of America

Timeline & Enrollment

Phase 3

Jul 08, 2021

Feb 20, 2023

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 gallbladder
Pure hypercholesterolaemia
Other disorders of lipoprotein metabolism
Disorder of lipoprotein metabolism, unspecified
Disorders of lipoprotein metabolism and other lipidaemias

Data Source

ClinicalTrials.gov

NCT04964544

Non-Device Trial