HyperlipidemiasPhase 4NCT00645424
A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol
A Phase 4 study testing atorvastatin in people with Hyperlipidemias, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in Taiwan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 5 sitesTaiwan
- Study dates
- Dec 2003to Oct 2004
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
- Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of <400 mg/dL
Who cannot join
- Type I diabetes mellitus
- Secondary causes of high cholesterol
- Elevated liver enzymes
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Pfizer Investigational Site
Kaohsiung City
Pfizer Investigational Site
Kaohsiung Hsien
Pfizer Investigational Site
Taichung
Pfizer Investigational Site
Taipei
Pfizer Investigational Site
Taoyuan Hsien
About this study
Official title: A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia
The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.
- Conditions
- Hyperlipidemias
- Being tested
- atorvastatin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
atorvastatinDrug
Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
atorvastatinDrug
Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: atorvastatin |
| Arm B | Experimental | Not described Receives: Drug: atorvastatin |
| Arm C | Experimental | Not described Receives: Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in LDL-C levels from baseline to Week 12
Measured: Week 12
Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12
Measured: Week 12
Secondary outcomes (7)
Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12
Measured: Weeks 4, 8, and 12
Adverse events at Weeks 4, 8, and 12
Measured: Baseline and at Weeks 4, 8, and 12
Clinical laboratory changes at Weeks 4, 8, and 12
Measured: Screening and at Weeks 4, 8, and 12
Vital signs at Weeks 4, 8, and 12
Measured: Screening and at Weeks 4, 8, and 12
Percentage change in LDL-C levels from baseline at Weeks 4 and 8
Measured: Weeks 4 and 8
Percentage of LDL-C responders at Weeks 4 and 8
Measured: Weeks 4 and 8
Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12
Measured: Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startDec 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- 155 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
- NCT00645424
- Sponsor's protocol ID
- A2581123
- Status last verified
- Feb 2021
- First submitted
- 24 Mar 2008
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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 Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00645424
- Acronym / sponsor ID
- A2581123
- Conditions
- Hyperlipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Oct 2004 (actual)
- First posted
- 27 Mar 2008 (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 and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: atorvastatin |
| Arm B | Experimental | Drug: atorvastatin |
| Arm C | Experimental | Drug: atorvastatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
- Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of <400 mg/dL
Key exclusion criteria (3 listed)
- Type I diabetes mellitus
- Secondary causes of high cholesterol
- Elevated liver enzymes
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 |
|---|---|---|
| atorvastatinAtorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks | Drug | Arm A |
| atorvastatinAtorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks | Drug | Arm B |
| atorvastatinAtorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks | Drug | Arm C |
Primary outcome
Percentage change in LDL-C levels from baseline to Week 12
Time frame: Week 12
Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12
Time frame: Week 12
7 secondary outcomes
Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12
Time frame: Weeks 4, 8, and 12
Adverse events at Weeks 4, 8, and 12
Time frame: Baseline and at Weeks 4, 8, and 12
Clinical laboratory changes at Weeks 4, 8, and 12
Time frame: Screening and at Weeks 4, 8, and 12
Vital signs at Weeks 4, 8, and 12
Time frame: Screening and at Weeks 4, 8, and 12
Percentage change in LDL-C levels from baseline at Weeks 4 and 8
Time frame: Weeks 4 and 8
Percentage of LDL-C responders at Weeks 4 and 8
Time frame: Weeks 4 and 8
Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12
Time frame: Weeks 4, 8, and 12
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.
Related trials for Hyperlipidemias
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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
5 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 in people with Hyperlipidemias, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in Taiwan.
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 3 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 5 sites in Taiwan. 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?
Percentage change in LDL-C levels from baseline to Week 12 (time frame: Week 12). 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 18 Feb 2021.