HDL CholesterolPhase 3NCT00389896
A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED)
A Phase 3 study testing MK0733 / Duration of Treatment: 18 Weeks in people with HDL Cholesterol, run by Organon and Co.
Trial summary
The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HDL Cholesterol
- What is being tested?
- MK0733 / Duration of Treatment: 18 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 26 Jul 2001to 4 Oct 2002
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has stable Type 2 diabetes mellitus at Visit 1.
- Patient meets screening criteria based on Visit 1 lab tests
Who cannot join
- Patient is pregnant, breastfeeding, or at risk of becoming pregnant
- Patient has heart disease, uncontrolled high blood pressure, or other significant disease
- Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Balanced, Three-Way Crossover Study to Evaluate the Efficacy of Simvastatin Therapy in Elevating HDL-C Levels in Patients With Type 2 Diabetic Dyslipidemia and Low HDL-C
The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.
- Conditions
- HDL Cholesterol
- Being tested
- MK0733 / Duration of Treatment: 18 Weeks, Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0733 / Duration of Treatment: 18 WeeksDrug
Comparator: placebo (unspecified) / Duration of Treatment: 18 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-C raising effects after 6 weeks
Measured: 6 weeks
Secondary outcomes (1)
Effect on other lipids and lipoproteins at 6 weeks
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 posted19 Oct 2006 (estimated)
- Study start26 Jul 2001
- Primary completion4 Oct 2002
- Study completion4 Oct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HDL CholesterolStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 150 participants
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
- NCT00389896
- Sponsor's protocol ID
- 0733-216
- Other IDs
- 2006_536
- Status last verified
- Feb 2022
- First submitted
- 18 Oct 2006
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Miller M, Dobs A, Yuan Z, Battisti WP, Palmisano J. The effect of simvastatin on triglyceride-rich lipoproteins in patients with type 2 diabetic dyslipidemia: a SILHOUETTE trial sub-study. Curr Med Res Opin. 2006 Feb;22(2):343-50. doi: 10.1185/030079906X80521.
PubMed 16466606Miller M, Dobs A, Yuan Z, Battisti WP, Borisute H, Palmisano J. Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C. Curr Med Res Opin. 2004 Jul;20(7):1087-94. doi: 10.1185/030079904125004105.
PubMed 15265253
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Balanced, Three-Way Crossover Study to Evaluate the Efficacy of Simvastatin Therapy in Elevating HDL-C Levels in Patients With Type 2 Diabetic Dyslipidemia and Low HDL-C
- ClinicalTrials.gov ID
- NCT00389896
- Acronym / sponsor ID
- 0733-216
- Conditions
- HDL Cholesterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2001 (actual)
- Primary completion
- 4 Oct 2002 (actual)
- Study completion
- 4 Oct 2002 (actual)
- First posted
- 19 Oct 2006 (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 see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has stable Type 2 diabetes mellitus at Visit 1.
- Patient meets screening criteria based on Visit 1 lab tests
Key exclusion criteria (3 listed)
- Patient is pregnant, breastfeeding, or at risk of becoming pregnant
- Patient has heart disease, uncontrolled high blood pressure, or other significant disease
- Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study
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 |
|---|---|---|
| MK0733 / Duration of Treatment: 18 Weeks | Drug | – |
| Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks | Drug | – |
Primary outcome
HDL-C raising effects after 6 weeks
Time frame: 6 weeks
1 secondary outcome
Effect on other lipids and lipoproteins at 6 weeks
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 16466606Miller M, Dobs A, Yuan Z, Battisti WP, Palmisano J. The effect of simvastatin on triglyceride-rich lipoproteins in patients with type 2 diabetic dyslipidemia: a SILHOUETTE trial sub-study. Curr Med Res Opin. 2006 Feb;22(2):343-50. doi: 10.1185/030079906X80521.
- Background: PubMed 15265253Miller M, Dobs A, Yuan Z, Battisti WP, Borisute H, Palmisano J. Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C. Curr Med Res Opin. 2004 Jul;20(7):1087-94. doi: 10.1185/030079904125004105.
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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 MK0733 / Duration of Treatment: 18 Weeks in people with HDL Cholesterol, 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 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 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?
HDL-C raising effects after 6 weeks (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 NCT00389896, which also lists 2 linked publications.
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.