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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,196 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-arm, interventional, phase III Self-Selection (SS) and Actual Use Study (AUS) using a technology assisted tool within a Web App. The open-label study will enroll approximately 1220 participants who qualify for treatment based on the data they enter into the Web App of which an estimated 1000 participants will ultimately proceed to the use phase.

Conditions

• High Cholesterol

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-08
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-07-16
• Last updated: 2024-10-30
• Results posted: 2024-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study