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Rosuvastatin Calcium

Phase 3

Acute Coronary Syndromes | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Oct 30, 2024

Target and mechanism

ModalitySmall molecule

Also known as rosuvastatin calcium with a Web App

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment825

FDA Designations

No designations recorded

Clinical trial landscape

Rosuvastatin Calcium · 6 trials · 7 indications

Phase 3 5Phase 1 1
NCT04964544Technology-Assisted Cholesterol Trial in Consumers (TACTiC)High Cholesterol
COMPLETED1,196 Analytics
NCT01078675An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial HypercholesterolaemiaFamilial Hypercholesterolaemia
COMPLETED315 Analytics
NCT00214630LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary SyndromesAcute Coronary Syndromes
COMPLETED825 Analytics
NCT00240318A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)Coronary Arteriosclerosis
COMPLETED450 Analytics
NCT00225589A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)Hypercholesteremia
COMPLETED840 Analytics
PHASE3COMPLETED
Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
High Cholesterol
NCT049645441,196
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PHASE3COMPLETED
An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
Familial Hypercholesterolaemia
NCT01078675315
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PHASE3COMPLETED
LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes
Acute Coronary Syndromes
NCT00214630825
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PHASE3COMPLETED
A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)
Coronary Arteriosclerosis
NCT00240318450
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PHASE3COMPLETED
A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)
Hypercholesteremia
NCT00225589840
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Study Endpoints

Primary Endpoints

Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population)
Study day -30 to -1, at initial TASS assessment

Proportion of participants that had a correct tass outcome at their initial TASS assessment

Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population)
From enrollment to end of the home use period at 180 days, at final TASS Assessment

Proportion of participants that had a correct tass outcome at their final TASS assessment

Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population)
From enrollment to end of the home use period at 180 days, at final assessment
Percent Change From Baseline in LDL-C
At Month 3, Month 12 and Month 24

Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.

Sexual Maturation by Tanner Staging at Baseline
At Baseline

Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.

Single Dose PK - Cmax
Serial blood samples over 24 hours.

Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing

Percent Change From Baseline in Height
At Month 12 and Month 24

One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.

Sexual Maturation by Tanner Staging at Month 12
At Baseline

Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.

Sexual Maturation by Tanner Staging at Month 24
At Baseline

Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.

Single Dose PK - Tmax
Serial blood samples over 24 hours

Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing

Single Dose PK - AUC(0-24)
Serial blood samples over 24 hours

Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing

Reduction of LDL-C following 12 weeks of treatment
to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS
Assess the effects of rosuvastatin treatment on the change in the mean maximum intima media thickness (IMT) of the 12 vessel segments: the near & far walls of the CCA, the carotid bulb & the ICA
Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers
Scheduled times during the 18 days that the study drug is taken
Blood levels for assessment of pharmacodynamic (lipid) parameters
Days -1 and 18

Secondary Endpoints

Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population)
From enrollment to end of the home use period at 180 days
Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population)
From enrollment to end of the home use period at 180 days
Participants Who Self-Identify a Do Not Use Warning Also Identified by the CMOG at Final Use Assessment(Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)
From enrollment to end of the home use period at 180 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open Label, Single Arm Technology-Assisted Cholesterol TrialOTHEROpen Label Single Arm study in All-comers population who self-report having concern about high cholesterol or heart health
1EXPERIMENTAL -
Rosuvastatin CalciumEXPERIMENTAL -

Interventions

NameTypeDescription
5 mg rosuvastatin calcium with a Web App (combination product)COMBINATION_PRODUCTThe 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.
rosuvastatin calciumDRUG5 mg, oral, once daily, 24 months
atorvastatinDRUG -
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Males, 20-75 years of age 2. Females, 20-75 years of age (This inclusion criterion will be applied until 50 females under the age of 50 years complete the initial TASS assessment in the Web App). After this quota of 50 females under the age of 50 years old is met, the inclusi...

Countries:United StatesBelgiumCanadaNetherlandsNorwayCosta RicaEl SalvadorMoroccoPanamaAustraliaFranceItalySpainCzechiaFinlandGermanyTaiwan
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