CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,196 enrolled
Drug / intervention
5 mg rosuvastatin calcium with a Web App (combination product)combination
Likely dose
5 mg rosuvastatin calcium with a Web App (combination product)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04964544
NCT04964544Phase 3Completed
CompareCT.gov

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·interventional·Posted Jul 16, 2021·Updated Oct 30, 2024

In Brief

A Phase 3 clinical trial evaluating 5 mg rosuvastatin calcium with a Web App (combination product) for High Cholesterol. Completed, enrolled 1,196 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh Cholesterol
CountriesUnited States
CollaboratorsConcentrics Research, Idea Evolver, The Cleveland Clinic

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJul 16, 2021
Enrollment StartJul 8, 2021
Primary CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.0 years ago

Interventions

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

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.