Diabetes Mellitus, Type 2Phase 3NCT00541697
Eze/Simva Switch Study in Diabetics (0653A-807)
A Phase 3 study testing MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks and Comparator: atorvastatin / Duration of Treatment: 6 Weeks in people with Diabetes Mellitus, Type 2, run by Organon and Co.
Trial summary
A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks and Comparator: atorvastatin / Duration of Treatment: 6 Weeks
- How many people
- 648 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2005to 14 Oct 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently being treated with Atorvastatin 10 mg for at least 6 weeks
- Have Type 2 Diabetes
- Weight must be stable for more than 6 weeks before entering the study
Who cannot join
- Consume more than 14 alcoholic drinks per week.
- Pregnant or lactating
- Have taken another investigation drug within 3 months of starting this study
- History of congestive heart failure, heart attack, coronary artery bypass surgery
- Uncontrolled high blood pressure
- HIV positive
- History of cancer in the last 5 years
About this study
Official title: A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.
A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks, Comparator: atorvastatin / Duration of Treatment: 6 Weeks
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 WeeksDrug
Comparator: atorvastatin / Duration of Treatment: 6 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment
Measured: 6 Weeks
Secondary outcomes (1)
Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study start19 Jan 2005
- Primary completion28 Sep 2005
- Study completion14 Oct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541697
- Sponsor's protocol ID
- 0653A-807
- Other IDs
- MK0653A-807, 2007_645
- Status last verified
- Feb 2022
- First submitted
- 5 Oct 2007
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Constance C, Westphal S, Chung N, Lund M, McCrary Sisk C, Johnson-Levonas AO, Massaad R, Allen C. Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2007 Jul;9(4):575-84. doi: 10.1111/j.1463-1326.2007.00725.x. Epub 2007 Apr 19.
PubMed 17451425
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.
- ClinicalTrials.gov ID
- NCT00541697
- Acronym / sponsor ID
- 0653A-807
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2005 (actual)
- Primary completion
- 28 Sep 2005 (actual)
- Study completion
- 14 Oct 2005 (actual)
- First posted
- 10 Oct 2007 (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.
A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently being treated with Atorvastatin 10 mg for at least 6 weeks
- Have Type 2 Diabetes
- Weight must be stable for more than 6 weeks before entering the study
Key exclusion criteria (7 listed)
- Consume more than 14 alcoholic drinks per week.
- Pregnant or lactating
- Have taken another investigation drug within 3 months of starting this study
- History of congestive heart failure, heart attack, coronary artery bypass surgery
- Uncontrolled high blood pressure
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 |
|---|---|---|
| MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks | Drug | – |
| Comparator: atorvastatin / Duration of Treatment: 6 Weeks | Drug | – |
Primary outcome
Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment
Time frame: 6 Weeks
1 secondary outcome
Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment
Time frame: 6 Weeks
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 15 Aug 2024.
- Background: PubMed 17451425Constance C, Westphal S, Chung N, Lund M, McCrary Sisk C, Johnson-Levonas AO, Massaad R, Allen C. Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2007 Jul;9(4):575-84. doi: 10.1111/j.1463-1326.2007.00725.x. Epub 2007 Apr 19.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks and Comparator: atorvastatin / Duration of Treatment: 6 Weeks in people with Diabetes Mellitus, Type 2, run by Organon and Co.
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 7 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 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00541697, which also lists 1 linked publication.
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 15 Aug 2024.