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Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

NCT04964544 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1196

Last updated 2024-10-30

Study results available
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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.

Conditions

Interventions

COMBINATION_PRODUCT

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

The combination product will be a Drug (Rosuvastatin calcium 5 mg) and Software as a Medical Device (Web App that features a Technology-Assisted Self-Selection (TASS) tool). Rosuvastatin calcium 5 mg will be taken orally, 1 tablet daily to use for lowering cholesterol, a key risk factor that can lead to heart disease.

Sponsors & Collaborators

  • Concentrics Research

    collaborator OTHER

  • Idea Evolver

    collaborator INDUSTRY

  • The Cleveland Clinic

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • William C. Miller, M.D. · Concentrics Central Medical Operations Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2023-03-01
Completion
2023-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04964544 on ClinicalTrials.gov