FlushingPhase 2NCT00536237
MK0524A Phase IIb Study (0524A-011)(COMPLETED)
A Phase 2 study testing Comparator: niacin / Duration of Treatment: 17 Weeks and MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks in people with Flushing, run by Merck Sharp & Dohme LLC.
Trial summary
Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone. Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Flushing
- What is being tested?
- Comparator: niacin / Duration of Treatment: 17 Weeks and MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Dec 2006
- 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
- Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening
- Must be willing to complete electronic diary
Who cannot join
- Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
- You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
- You consume more than 14 alcoholic drinks per week or more than 2 drinks per day
About this study
Official title: Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients
Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.
Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.
- Conditions
- Flushing
- Being tested
- Comparator: niacin / Duration of Treatment: 17 Weeks, MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks, Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks
- Medical subject headings
- Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: niacin / Duration of Treatment: 17 WeeksDrug
MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 WeeksDrug
Comparator: placebo (unspecified) / Duration of Treatment: 17 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of MK0524A on lipids and blood glucose
Measured: 17 Weeks
Secondary outcomes (1)
To establish the dose for limiting flushing symptoms induced by NIASPAN (R)
Measured: 17 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startAug 2004
- Primary completionFeb 2005
- Study completionDec 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 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
- NCT00536237
- Sponsor's protocol ID
- 0524A-011
- Other IDs
- MK0524A-011, 2007_618
- Status last verified
- Aug 2015
- First submitted
- 26 Sep 2007
- Last updated
- 25 Aug 2015
- Results posted
- No
Publications
Paolini JF, Mitchel YB, Reyes R, Kher U, Lai E, Watson DJ, Norquist JM, Meehan AG, Bays HE, Davidson M, Ballantyne CM. Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am J Cardiol. 2008 Mar 1;101(5):625-30. doi: 10.1016/j.amjcard.2007.10.023. Epub 2007 Dec 21.
PubMed 18308010
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients
- ClinicalTrials.gov ID
- NCT00536237
- Acronym / sponsor ID
- 0524A-011
- Conditions
- Flushing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 27 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.
Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.
Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening
- Must be willing to complete electronic diary
Key exclusion criteria (3 listed)
- Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
- You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
- You consume more than 14 alcoholic drinks per week or more than 2 drinks per day
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: niacin / Duration of Treatment: 17 Weeks | Drug | – |
| MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks | Drug | – |
| Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks | Drug | – |
Primary outcome
To determine the effect of MK0524A on lipids and blood glucose
Time frame: 17 Weeks
1 secondary outcome
To establish the dose for limiting flushing symptoms induced by NIASPAN (R)
Time frame: 17 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 25 Aug 2015.
- Background: PubMed 18308010Paolini JF, Mitchel YB, Reyes R, Kher U, Lai E, Watson DJ, Norquist JM, Meehan AG, Bays HE, Davidson M, Ballantyne CM. Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am J Cardiol. 2008 Mar 1;101(5):625-30. doi: 10.1016/j.amjcard.2007.10.023. Epub 2007 Dec 21.
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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 Comparator: niacin / Duration of Treatment: 17 Weeks and MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 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 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 25 Aug 2015. 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 determine the effect of MK0524A on lipids and blood glucose (time frame: 17 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 NCT00536237, 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 25 Aug 2015.