HypercholesterolemiaPhase 4NCT00141141
Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
A Phase 4 study testing Atorvastatin and Simvastatin in people with Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 35 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment phase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Atorvastatin and Simvastatin
- How many people
- 383 participants
- Where
- 35 sitesItaly
- Study dates
- Jan 2004to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus
- LDL-C > 130 mg/dL
Who cannot join
- Insulin therapy
- Clinically relevant organ disease (creatininemia >2mg/dL, CHF NYHA III and IV)
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Italy35 sites
Pfizer Investigational Site
Ancona, 60100
Pfizer Investigational Site
Asti, 14100
Pfizer Investigational Site
Bari, 70124
Pfizer Investigational Site
Cagliari, 09134
Pfizer Investigational Site
Campobasso, 86100
Pfizer Investigational Site
Casarano, Lecce, 73043
Pfizer Investigational Site
Catania, 95124
Pfizer Investigational Site
Catania, 95126
Pfizer Investigational Site
Catanzaro, 88100
Pfizer Investigational Site
Ferrara, 44100
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Messina, 98158
Pfizer Investigational Site
Mestre, VE, 30174
Pfizer Investigational Site
Milan, 20142
Pfizer Investigational Site
Milan, 20145
Pfizer Investigational Site
Milan, 20157
Pfizer Investigational Site
Naples, 80100
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Orbassano, Torino, 10043
Pfizer Investigational Site
Palermo, 90127
Pfizer Investigational Site
Parma, 43100
Pfizer Investigational Site
Pavia, PV, 27100
Pfizer Investigational Site
Perugia, 06100
Pfizer Investigational Site
Pisa, 56124
Pfizer Investigational Site
Potenza, 85100
Pfizer Investigational Site
Rimini, 47900
Pfizer Investigational Site
Roma, 00155
Pfizer Investigational Site
Roma, 00161
Pfizer Investigational Site
Roma, 00163
Pfizer Investigational Site
Roma, 00168
Pfizer Investigational Site
S. Benedetto DEL Tronto, Ascoli Piceno, 63039
Pfizer Investigational Site
S. Benedetto Del Tronto (AP), 63039
Pfizer Investigational Site
S.Pietro Vernotico, Brindisi
Pfizer Investigational Site
Torino, 10154
Pfizer Investigational Site
Udine, 33100
About this study
Official title: A Phase IV, Multicenter, Randomized, Open Label Study To Evaluate The Efficacy And Safety Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment phase.
- Conditions
- Hypercholesterolemia
- Being tested
- Atorvastatin, Simvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
SimvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the decrease of LDL-C after 24 weeks of treatment.
Secondary outcomes (2)
To evaluate the changes from baseline of targeted blood markers.
To evaluate safety of Atorvastatin vs Simvastatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJan 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 383 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
- NCT00141141
- Sponsor's protocol ID
- A2581053
- Status last verified
- Feb 2021
- First submitted
- 30 Aug 2005
- Last updated
- 18 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicenter, Randomized, Open Label Study To Evaluate The Efficacy And Safety Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00141141
- Acronym / sponsor ID
- A2581053
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 study is to evaluate the efficacy of Atorvastin vs Simvastatin in decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of type 2 diabetes mellitus
- LDL-C > 130 mg/dL
Key exclusion criteria (2 listed)
- Insulin therapy
- Clinically relevant organ disease (creatininemia >2mg/dL, CHF NYHA III and IV)
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 | Drug | – |
| Simvastatin | Drug | – |
Primary outcome
To evaluate the decrease of LDL-C after 24 weeks of treatment.
2 secondary outcomes
To evaluate the changes from baseline of targeted blood markers.
To evaluate safety of Atorvastatin vs Simvastatin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- 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
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin and Simvastatin in people with Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 35 sites in Italy.
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 2 inclusion and 2 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 18 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 35 sites in Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the decrease of LDL-C after 24 weeks of treatment.. 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 18 Feb 2021.