FlushingPhase 3NCT00533611
Effect of MK0524A on Flushing Caused by Niacin (0524A-056)
A Phase 3 study testing MK0524A, /Duration of Treatment : 4 Weeks and Comparator : niacin /Duration of Treatment : 1 Weeks in people with Flushing, run by Merck Sharp & Dohme LLC.
Trial summary
The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Flushing
- What is being tested?
- MK0524A, /Duration of Treatment : 4 Weeks and Comparator : niacin /Duration of Treatment : 1 Weeks
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Aug 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or female between 18 and 70 years of age
- Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study
Who cannot join
- Patient has a history of hypersensitivity to niacin or niacin-containing products
- Patient is currently experiencing menopausal hot flashes
- Patient consumes more than 2 alcoholic beverages per day
- Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
- Patient engages in vigorous exercise or an aggressive diet regimen
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients
The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.
- Conditions
- Flushing
- Being tested
- MK0524A, /Duration of Treatment : 4 Weeks, Comparator : niacin /Duration of Treatment : 1 Weeks
- Medical subject headings
- Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0524A, /Duration of Treatment : 4 WeeksDrug
Comparator : niacin /Duration of Treatment : 1 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.
Measured: Over 1 week
Secondary outcomes (1)
MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).
Measured: Daily
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 2007
- Primary completionAug 2007
- Study completionAug 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 FlushingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants
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
- NCT00533611
- Sponsor's protocol ID
- 0524A-056
- Other IDs
- MK0524A-056, 2007_604
- Status last verified
- Feb 2017
- First submitted
- 19 Sep 2007
- Last updated
- 17 Feb 2017
- Results posted
- No
Publications
Kush D, Hu DY, Ye P, Kim HS, Chen E, Sirah W, McCrary Sisk C, Paolini JF, Maccubbin D. Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. Cardiology. 2009;114(3):192-8. doi: 10.1159/000228585. Epub 2009 Jul 15.
PubMed 19602880
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients
- ClinicalTrials.gov ID
- NCT00533611
- Acronym / sponsor ID
- 0524A-056
- Conditions
- Flushing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 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.
The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is male or female between 18 and 70 years of age
- Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study
Key exclusion criteria (5 listed)
- Patient has a history of hypersensitivity to niacin or niacin-containing products
- Patient is currently experiencing menopausal hot flashes
- Patient consumes more than 2 alcoholic beverages per day
- Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
- Patient engages in vigorous exercise or an aggressive diet regimen
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 |
|---|---|---|
| MK0524A, /Duration of Treatment : 4 Weeks | Drug | – |
| Comparator : niacin /Duration of Treatment : 1 Weeks | Drug | – |
Primary outcome
MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.
Time frame: Over 1 week
1 secondary outcome
MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).
Time frame: Daily
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 17 Feb 2017.
- Background: PubMed 19602880Kush D, Hu DY, Ye P, Kim HS, Chen E, Sirah W, McCrary Sisk C, Paolini JF, Maccubbin D. Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. Cardiology. 2009;114(3):192-8. doi: 10.1159/000228585. Epub 2009 Jul 15.
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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 MK0524A, /Duration of Treatment : 4 Weeks and Comparator : niacin /Duration of Treatment : 1 Weeks in people with Flushing, 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 5 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 17 Feb 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?
MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme. (time frame: Over 1 week). 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 NCT00533611, 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 17 Feb 2017.