DyslipidemiaPhase 3NCT00664287
Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)
A Phase 3 study testing niacin (+) laropiprant in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- niacin (+) laropiprant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Nov 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older and on a stable dose of lipid therapy
Who cannot join
- Patients lipid level is outside the recommended range
- Patients that are HIV positive
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Dyslipidemic Patients Deemed Appropriate for Further Lipid Modification.
The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.
- Conditions
- Dyslipidemia
- Being tested
- niacin (+) laropiprant, placebo (unspecified)
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niacin (+) laropiprantDrug
Also called MK0524A
Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.
placebo (unspecified)Drug
Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients will remain on existing lipid-modifying therapy throughout the study. Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study. Receives: Drug: niacin (+) laropiprant |
| Group 2 | Placebo comparator | Patients will remain on existing lipid-modifying therapy throughout the study. Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study. Receives: Drug: placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks.
Measured: 3 months
Secondary outcomes (1)
Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- 0 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
- NCT00664287
- Sponsor's protocol ID
- 0524A-082
- Other IDs
- 2008_504
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2008
- Last updated
- 9 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Dyslipidemic Patients Deemed Appropriate for Further Lipid Modification.
- ClinicalTrials.gov ID
- NCT00664287
- Acronym / sponsor ID
- 0524A-082
- Conditions
- Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2009 (estimated)
- First posted
- 22 Apr 2008 (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 test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: niacin (+) laropiprantPatients will remain on existing lipid-modifying therapy throughout the study. Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study. |
| Group 2 | Placebo comparator | Drug: placebo (unspecified)Patients will remain on existing lipid-modifying therapy throughout the study. Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age or older and on a stable dose of lipid therapy
Key exclusion criteria (2 listed)
- Patients lipid level is outside the recommended range
- Patients that are 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 |
|---|---|---|
| niacin (+) laropiprantAlso: MK0524AGroup 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study. | Drug | Group 1 |
| placebo (unspecified)Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study. | Drug | Group 2 |
Primary outcome
Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks.
Time frame: 3 months
1 secondary outcome
Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks.
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
Related trials for Dyslipidemia
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
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 niacin (+) laropiprant in people with Dyslipidemia, 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 1 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: withdrawn, as of the sponsor's last update on 9 Apr 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2015.