HypercholesterolemiaPhase 3NCT00092846
A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)
A Phase 3 study testing MK0803, lovastatin and Self-Management System in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the ability of patients with intermediate risk of heart disease to appropriately use a Self-Management System. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- MK0803, lovastatin and Self-Management System
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2002to 1 Sep 2003
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to read and understand English without assistance.
- For Males: Minimum age 45 years and Maximum age N/A (No limit).
- For Females: Minimum age 55 years and Maximum age N/A (No limit).
Who cannot join
- Pregnant or nursing
- Drug allergy
About this study
Official title: A Consumer Use Study of OTC Lovastatin (CUSTOM): A 6-Month Consumer Behavior Study of the Lovastatin OTC Self-Management System
The purpose of this study is to evaluate the ability of patients with intermediate risk of heart disease to appropriately use a Self-Management System.
Read the detailed description
The duration of treatment is 6 months.
- Conditions
- Hypercholesterolemia
- Being tested
- MK0803, lovastatin, Self-Management System
- Keywords
- High Blood Cholesterol Levels
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0803, lovastatinDrug
Self-Management SystemBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who make appropriate decision for self-management.
Secondary outcomes (1)
Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2004 (estimated)
- Study start4 Dec 2002
- Primary completion1 Sep 2003
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 HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT00092846
- Sponsor's protocol ID
- 0803-084
- Other IDs
- 2004_061
- Status last verified
- Sep 2017
- First submitted
- 23 Sep 2004
- Last updated
- 2 Oct 2017
- Results posted
- No
Publications
Melin JM, Struble WE, Tipping RW, Reynolds JM, Vassil TC, Levy SJ, Petrohoy TM, Midgette P, Hemwall EL, Levine JG, Irvin JD. A Consumer Use Study of Over-The-Counter lovastatin (CUSTOM). Am J Cardiol. 2004 Nov 15;94(10):1243-8. doi: 10.1016/j.amjcard.2004.08.007.
PubMed 15541238
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Consumer Use Study of OTC Lovastatin (CUSTOM): A 6-Month Consumer Behavior Study of the Lovastatin OTC Self-Management System
- ClinicalTrials.gov ID
- NCT00092846
- Acronym / sponsor ID
- 0803-084
- Conditions
- Hypercholesterolemia
- Keywords
- High Blood Cholesterol Levels
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2002 (actual)
- Primary completion
- 1 Sep 2003 (actual)
- First posted
- 28 Sep 2004 (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 ability of patients with intermediate risk of heart disease to appropriately use a Self-Management System.
Detailed description
The duration of treatment is 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be able to read and understand English without assistance.
- For Males: Minimum age 45 years and Maximum age N/A (No limit).
- For Females: Minimum age 55 years and Maximum age N/A (No limit).
Key exclusion criteria (2 listed)
- Pregnant or nursing
- Drug allergy
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 |
|---|---|---|
| MK0803, lovastatin | Drug | – |
| Self-Management System | Behavioural | – |
Primary outcome
Percentage of patients who make appropriate decision for self-management.
1 secondary outcome
Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.
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 2 Oct 2017.
- Background: PubMed 15541238Melin JM, Struble WE, Tipping RW, Reynolds JM, Vassil TC, Levy SJ, Petrohoy TM, Midgette P, Hemwall EL, Levine JG, Irvin JD. A Consumer Use Study of Over-The-Counter lovastatin (CUSTOM). Am J Cardiol. 2004 Nov 15;94(10):1243-8. doi: 10.1016/j.amjcard.2004.08.007.
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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 MK0803, lovastatin and Self-Management System in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC.
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 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 2 Oct 2017. 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?
Percentage of patients who make appropriate decision for self-management.. 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 NCT00092846, 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 2 Oct 2017; AzTrials last refreshed its copy on 2 Nov 2026.