Lipid Metabolism DisorderNCT01071278

Lipid Management in Clinical Practice (MK-0524A-115)

An observational study of Lipid Metabolism Disorder, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lipid Metabolism Disorder
How many people: 2,390 participants
Where: No sites listed yet
Study dates: Oct 2009to Feb 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Patients in routine medical care either statutorily health insured or privately insured

Who may be able to join

Patients are 18 years of age or older with lipid disorder treated with nicotinic acid/laropiprant

Who cannot join

Patient is currently participating in a clinical trial

About this study

Official title: Lipid Management in Clinical Practice

The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions.

Conditions: Lipid Metabolism Disorder
Keywords: Lipid metabolism disorder
Medical subject headings: Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01071278
Study group	Role	What they receive
Patients treated within a disease management program		Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
Patients treated outside a disease management program		Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Lipid Panel Control
Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).
Measured: From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)

Secondary outcomes (1)

Number of Participants Who Reported Adverse Events
Measured: Up to 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Feb 2011

First posted19 Feb 2010 (estimated)
Study startOct 2009
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lipid Metabolism DisorderStudies 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: Observational
Time perspective: Prospective
Enrolment: 2,390 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01071278
Sponsor's protocol ID: 0524A-115
Other IDs: 2010_011
Status last verified: Jul 2015
First submitted: 17 Feb 2010
Last updated: 11 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
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All Lipid Metabolism Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lipid Management in Clinical Practice
ClinicalTrials.gov ID: NCT01071278
Acronym / sponsor ID: 0524A-115
Conditions: Lipid Metabolism Disorder
Keywords: Lipid metabolism disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 2,390 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 19 Feb 2010 (estimated)
Results: Posted 7 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions.

Study design

Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Patients treated within a disease management program	–	–Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
Patients treated outside a disease management program	–	–Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients in routine medical care either statutorily health insured or privately insured

Key inclusion criteria (1 listed)

Patients are 18 years of age or older with lipid disorder treated with nicotinic acid/laropiprant

Key exclusion criteria (1 listed)

Patient is currently participating in a clinical trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Lipid Panel Control
Time frame: From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)
Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).

1 secondary outcome

Number of Participants Who Reported Adverse Events
Time frame: Up to 22 weeks

Results and safety

Results posted to the registry on 7 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Evaluable Participants	2,390	1,677

Primary outcome: Number of Participants With Lipid Panel Control

Time frame: From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22). Number. Unit: participants

Measure	Patients Treated Within a Disease Management Program n = 1224	Patients Treated Outside a Disease Management Program n = 1072
1 lipid parameter	249	192
2 lipid parameters	245	231
3 lipid parameters	232	194
No lipid parameter	70	33
Not Reported	428	422

Population analysed: Results are for the Intent-to-Treat (ITT) Population. Information regarding the participation in a disease management program was not reported for 63 participants in the ITT Population.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Evaluable Participants	20 of 2,390 (0.8%)	0 of 2,390 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lipid Metabolism Disorder

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases

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?

An observational study of Lipid Metabolism Disorder, 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 1 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 11 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Lipid Panel Control (time frame: From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)). 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 NCT01071278.

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 11 Aug 2015.