HypercholesterolemiaPhase 3NCT01964326
Actual Use Trial of Atorvastatin Calcium 10 mg
A Phase 3 study testing Atorvastatin calcium 10 mg in people with Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 37 sites in United States.
Trial summary
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Atorvastatin calcium 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,311 participants
- Where
- 37 sitesUnited States
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age (19 in Alabama).
- Provide written informed consent.
- Never participated in a study about cholesterol medicines.
Who cannot join
- Females subjects who are pregnant or breastfeeding.
- Subjects with active liver disease.
- Subjects taking cyclosporine.
- Subjects with a known allergy to atorvastatin calcium.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Duran Central Pharmacy
Albuquerque, New Mexico, 87104
Sam's Regent Pharmacy
Albuquerque, New Mexico, 87109
Catonsville Pharmacy
Baltimore, Maryland, 21228
Family Prescription Center
Bethlehem, Pennsylvania, 18015
Mountain West Apothecary
Bountiful, Utah, 84010
Sutton Family Pharmacy
Dalton, Georgia, 30721
Kemper Drug
Elk River, Minnesota, 55330
Jim's Pharmacy
Enumclaw, Washington, 98022
Garden Drug
Fort Lauderdale, Florida, 33309
Goodrich Pharmacy
Fridley, Minnesota, 55432
Wynn's Pharmacy Inc.
Griffin, Georgia, 30224
T.B. Bond Pharmacy
Hillsboro, Texas, 76645
Robert's Discount Pharmacy
Hoover, Alabama, 35226
Inwood Pharmacy
Houston, Texas, 77070
Albers' Medical Pharmacy
Kansas City, Missouri, 64111
Ostrom Drugs
Kenmore, Washington, 98028
Bi-Rite Quality Pharmacies
La Habra, California, 90631
Pharmacy at the Pig
McCalla, Alabama, 35111
Community Clinical Pharmacy
Mesa, Arizona, 85202
Texas Road Pharmacy
Monroe, New Jersey, 08831
Montpelier Pharmacy, Inc.
Montpelier, Virginia, 23192
Northfield Pharmacy
Northfield, Minnesota, 55057
Pill Box Pharmacy and Medical Supply
Pembroke Pines, Florida, 33026
Melrose Pharmacy
Phoenix, Arizona, 85013
Pinson Discount Drugs
Pinson, Alabama, 35126
Parkview Compounding Pharmacy
Rancho Cucamonga, California, 91730
Lafayette Pharmacy
Richmond, Virginia, 23221
Summerfield Pharmacy
Riverview, Florida, 33569
Cub Pharmacy
Rosemount, Minnesota, 55068
Ridgeview Pharmacy
Roy, Utah, 84067
Goodrich Pharmacy
Saint Francis, Minnesota, 55070
The Apothecary Shoppe
Salt Lake City, Utah, 84102
The Medicine Center
Salt Lake City, Utah, 84121
Countryside Pharmacy
Savannah, Missouri, 64485
Katterman's Sand Point Professional Pharmacy
Seattle, Washington, 98105
Brick Street Pharmacy
Tyler, Texas, 75701
Family Plaza Pharmacy
West Jordan, Utah, 84088
About this study
Official title: A Multicenter, Actual Use Trial In A Simulated Over-the-counter Environment Of Atorvastatin Calcium 10 Mg
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
- Conditions
- Hypercholesterolemia
- Being tested
- Atorvastatin calcium 10 mg
- Keywords
- atorvastatin, Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin calcium 10 mgDrug
Atorvastatin calcium 10 mg tablet to be administered orally every day
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin calcium 10 mg | Experimental | Not described Receives: Drug: Atorvastatin calcium 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level
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.
Measured: Day 1 up to Week 26
Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results
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.
Measured: Day 1 up to Week 26
Secondary outcomes (2)
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
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. 'Ask a doctor or pharmacist before use' medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy.
Measured: 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
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The "Stop use and ask a doctor" symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days' timeframe.
Measured: Day 1 up to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Masking
- None (open label)
- Enrolment
- 1,311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964326
- Sponsor's protocol ID
- A2581189
- Status last verified
- Feb 2021
- First submitted
- 14 Oct 2013
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Actual Use Trial In A Simulated Over-the-counter Environment Of Atorvastatin Calcium 10 Mg
- ClinicalTrials.gov ID
- NCT01964326
- Acronym / sponsor ID
- A2581189
- Conditions
- Hypercholesterolemia
- Keywords
- atorvastatin, Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,311 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Posted 27 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin calcium 10 mg | Experimental | Drug: Atorvastatin calcium 10 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age (19 in Alabama).
- Provide written informed consent.
- Never participated in a study about cholesterol medicines.
Key exclusion criteria (4 listed)
- Females subjects who are pregnant or breastfeeding.
- Subjects with active liver disease.
- Subjects taking cyclosporine.
- Subjects with a known allergy to atorvastatin calcium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin calcium 10 mgAtorvastatin calcium 10 mg tablet to be administered orally every day | Drug | Atorvastatin calcium 10 mg |
Primary outcome
Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level
Time frame: 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
Time frame: 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.
2 secondary outcomes
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
Time frame: 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
Time frame: Day 1 up to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin calcium 10 mg in people with Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level (time frame: Day 1 up to Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.