HypercholesteremiaPhase 3NCT00376584
Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)
A Phase 3 study testing MK-0524A and ER Niacin in people with Hypercholesteremia and Hyperlipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesteremia, Hyperlipidemia
- What is being tested?
- MK-0524A and ER Niacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 825 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jan 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 appropriate candidate for niacin therapy
- Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1
- Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1
- Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1
- Patient has TG <500 mg/dL (5.65 mmol/L) at V1
- A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria
- ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA
Who cannot join
- Patients with unstable doses of medications
- Pregnant or lactating women, or women intending to become pregnant are excluded
- Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
- Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)
About this study
Official title: A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin
This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.
- Conditions
- Hypercholesteremia, Hyperlipidemia
- Being tested
- MK-0524A, ER Niacin, Placebo
- Keywords
- Primary Hypercholesteremia, Mixed Hyperlipidemia
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0524ADrug
ER NiacinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo → MK-0524A 2g | Placebo comparator | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days). Receives: Drug: MK-0524A; Drug: Placebo |
| Placebo → Extended Release (ER)-Niacin 2g | Active comparator | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days) Receives: Drug: ER Niacin; Drug: Placebo |
| MK-0524A 2g | Experimental | Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks). Receives: Drug: MK-0524A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Flushing Severity Score (GFSS) during 7 days of treatment
Measured: during 7 days of treatment
Secondary outcomes (2)
Percentage of Participants Who Experience at Least 1 Adverse Event
Measured: up to 10 weeks
Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesteremiaStudies 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
- 825 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
- NCT00376584
- Sponsor's protocol ID
- 0524A-023
- Other IDs
- MK0524A-023, 2006_504
- Status last verified
- Feb 2017
- First submitted
- 14 Sep 2006
- Last updated
- 16 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin
- ClinicalTrials.gov ID
- NCT00376584
- Acronym / sponsor ID
- 0524A-023
- Conditions
- Hypercholesteremia, Hyperlipidemia
- Keywords
- Primary Hypercholesteremia, Mixed Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Sep 2006 (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.
This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo → MK-0524A 2g | Placebo comparator | Drug: MK-0524A, Drug: PlaceboFollowing an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days). |
| Placebo → Extended Release (ER)-Niacin 2g | Active comparator | Drug: ER Niacin, Drug: PlaceboFollowing an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days) |
| MK-0524A 2g | Experimental | Drug: MK-0524AFollowing an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is appropriate candidate for niacin therapy
- Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1
- Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1
- Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1
- Patient has TG <500 mg/dL (5.65 mmol/L) at V1
Key exclusion criteria (4 listed)
- Patients with unstable doses of medications
- Pregnant or lactating women, or women intending to become pregnant are excluded
- Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
- Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)
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 |
|---|---|---|
| MK-0524A | Drug | MK-0524A 2g, Placebo → MK-0524A 2g |
| ER Niacin | Drug | Placebo → Extended Release (ER)-Niacin 2g |
| Placebo | Drug | Placebo → Extended Release (ER)-Niacin 2g, Placebo → MK-0524A 2g |
Primary outcome
Global Flushing Severity Score (GFSS) during 7 days of treatment
Time frame: during 7 days of treatment
2 secondary outcomes
Percentage of Participants Who Experience at Least 1 Adverse Event
Time frame: up to 10 weeks
Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event
Time frame: up to 10 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 16 Feb 2017.
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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 MK-0524A and ER Niacin in people with Hypercholesteremia and Hyperlipidemia, 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 7 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 16 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. 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 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?
Global Flushing Severity Score (GFSS) during 7 days of treatment (time frame: during 7 days of treatment). 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 16 Feb 2017.