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Atorvastatin calcium

Phase 4FDA approved

Hypercholesterolemia | Small molecule | Metabolic |Viatris Inc.|Trials Updated: Feb 21, 2021

Atorvastatin calcium development status

FDA approval on record May 3, 2013
Approval holderOrganon
ApplicationNDA200153
Highest phase Phase 4 run by Jun Li (NCT03072121)
Phase scored for VTRSPhase 3
Registered trials 8 across 6 sponsors since Aug 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment1,311

FDA Designations

No designations recorded

Atorvastatin calcium clinical trials

Atorvastatin calcium · 1 trial · 1 indication

Phase 3 1
NCT01964326Actual Use Trial of Atorvastatin Calcium 10 mgHypercholesterolemia
COMPLETED1,311 Analytics
PHASE3COMPLETED
Actual Use Trial of Atorvastatin Calcium 10 mg
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level
Day 1 up to Week 26

Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.

Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results
Day 1 up to Week 26

Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (\>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results.

Secondary Endpoints

Percentage of Participants Taking an "Ask a Doctor or Pharmacist Before Use" Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication
Day 1 up to Week 26
Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled "Stop Use and Ask a Doctor" Symptoms
Day 1 up to Week 26
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Study Design & Arms

AllocationNA
MaskingNONE
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Atorvastatin calcium 10 mgEXPERIMENTAL -

Interventions

NameTypeDescription
Atorvastatin calcium 10 mgDRUGAtorvastatin calcium 10 mg tablet to be administered orally every day
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites37

Inclusion Criteria: * At least 18 years of age (19 in Alabama). * Provide written informed consent. * Never participated in a study about cholesterol medicines. Exclusion Criteria: * Females subjects who are pregnant or breastfeeding. * Subjects with active liver disease. * Subjects taking cyclos...

Countries:United States
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