HypercholesterolemiaPhase 2NCT00533312
MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)
A Phase 2 study testing MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks and Comparator : niacin / Duraton of Treatment: 4 Weeks in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC.
Trial summary
A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks and Comparator : niacin / Duraton of Treatment: 4 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jan 2007
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be between the ages of 18 and 70 years
- Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant
Who cannot join
- Patient has a history of peptic ulcer or gout
- Patient is sensitive to niacin or products containing niacin
- Patient drinks more than 2 alcoholic drinks per day
- Patient has certain heart disease, cancer, or is HIV positive
About this study
Official title: A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)
A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.
- Conditions
- Hypercholesterolemia
- Being tested
- Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks, MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks, Comparator : niacin / Duraton of Treatment: 4 Weeks
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator : placebo (unspecified) / Duraton of Treatment: 4 WeeksDrug
MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 WeeksDrug
Comparator : niacin / Duraton of Treatment: 4 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Measured: After 4 weeks
Secondary outcomes (1)
To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startApr 2005
- Primary completionJul 2005
- Study completionJan 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 407 participants (actual)
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
- NCT00533312
- Sponsor's protocol ID
- 0524A-026
- Other IDs
- 2007_619
- Status last verified
- Mar 2017
- First submitted
- 19 Sep 2007
- Last updated
- 7 Apr 2017
- Results posted
- No
Publications
Lai E, De Lepeleire I, Crumley TM, Liu F, Wenning LA, Michiels N, Vets E, O'Neill G, Wagner JA, Gottesdiener K. Suppression of niacin-induced vasodilation with an antagonist to prostaglandin D2 receptor subtype 1. Clin Pharmacol Ther. 2007 Jun;81(6):849-57. doi: 10.1038/sj.clpt.6100180. Epub 2007 Mar 28.
PubMed 17392721
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)
- ClinicalTrials.gov ID
- NCT00533312
- Acronym / sponsor ID
- 0524A-026
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 21 Sep 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 determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be between the ages of 18 and 70 years
- Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant
Key exclusion criteria (4 listed)
- Patient has a history of peptic ulcer or gout
- Patient is sensitive to niacin or products containing niacin
- Patient drinks more than 2 alcoholic drinks per day
- Patient has certain heart disease, cancer, or is HIV positive
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 |
|---|---|---|
| Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks | Drug | – |
| MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks | Drug | – |
| Comparator : niacin / Duraton of Treatment: 4 Weeks | Drug | – |
Primary outcome
To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Time frame: After 4 weeks
1 secondary outcome
To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Time frame: After 4 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 7 Apr 2017.
- Results publication: PubMed 17392721Lai E, De Lepeleire I, Crumley TM, Liu F, Wenning LA, Michiels N, Vets E, O'Neill G, Wagner JA, Gottesdiener K. Suppression of niacin-induced vasodilation with an antagonist to prostaglandin D2 receptor subtype 1. Clin Pharmacol Ther. 2007 Jun;81(6):849-57. doi: 10.1038/sj.clpt.6100180. Epub 2007 Mar 28.
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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 2 study testing MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks and Comparator : niacin / Duraton of Treatment: 4 Weeks 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 2 inclusion and 4 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 7 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo. (time frame: After 4 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 NCT00533312, 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 7 Apr 2017.