HyperlipoproteinemiaPhase 4NCT01239992

Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia

A Phase 4 study testing Niacin/ Laropiprant in people with Hyperlipoproteinemia and Metabolic Syndrome, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers of endothelial dysfunction and inflammation. Read more about this study

Who is it for?: Ages 19 to 70 years
Conditions the study is for: Hyperlipoproteinemia, Metabolic Syndrome
What is being tested?: Niacin/ Laropiprant
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteGermany
Study dates: Jun 2011to Jul 2013
Phase: Phase 4
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 19 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male subjects or postmenopausal female subjects aged between 19-70 years
High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least simvastatin 20 mg/d
HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl
Lipoprotein (a) < 30 mg/dl
Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus.
Without niacin therapy for at least 6 months
Dosage of any concomitant medication has been stable for at least 3 weeks
If female, postmenopausal (absence of menstruation for at least 12 months or absence of menstruation > 6 months with FSH > 40 ng/ml respectively oestrogen < 20 pg/ml)

Who cannot join

Subjects with additional causes for hyperlipoproteinemia
Diabetes mellitus or antidiabetic medication
Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
History of psychiatric disorder or cognitive impairment that would interfere with participation in the study
History of alcoholism
Contraindication against niacin and/or laropiprant

Show all 13Show fewer

Subject has participated in an investigational study within 30 days prior to study initiation
Fasting triglycerides >400 mg/dl
Life-threatening disease (e.g. cancer)
Renal insufficiency (GFR ≤ 30 ml/min )
Major hepatic impairment
Known allergic reaction/intolerance against niacin and/or laropiprant
Active peptic ulcer disease

Trial locations and contacts

1 site in 1 country.

Germany1 site

Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern
Munich, 81377

Other trials in Germany

About this study

Official title: Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia

Conditions: Hyperlipoproteinemia, Metabolic Syndrome
Being tested: Niacin/ Laropiprant
Medical subject headings: Hyperlipoproteinemias, Metabolic Syndrome

What participants receive

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

Niacin/ LaropiprantDrug
Also called Tredaptive, EU/1/08/459/001
1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily

Study groups in NCT01239992
Study group	Role	What they receive
Niacin/ Laropiprant	Experimental	Not described Receives: Drug: Niacin/ Laropiprant

What is being measured

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

Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test
Percent change of incremental AUC at 12 weeks compared to baseline.
Measured: baseline and 12 weeks after treatment

Secondary outcomes (2)

HDL Cholesterol
Percent change of HDL-cholesterol at 12 weeks compared to baseline.
Measured: baseline and 12 weeks after treatment
Fasting Triglycerides
Percent change of fasting triglycerides at 12 weeks compared to baseline
Measured: baseline and 12 weeks after treatment

Timeline

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

Jun 2011Jul 2013

First posted15 Nov 2010 (estimated)
Study startJun 2011
Primary completionJan 2013
Study completionJul 2013

Why it stopped: negative endpoint study resulting in withdrawal of study drug

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 HyperlipoproteinemiaStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01239992
Sponsor's protocol ID: KP-Niacin-2010
Other IDs: 2010-019954-42
Status last verified: Mar 2014
First submitted: 12 Nov 2010
Last updated: 10 Apr 2014
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?

See locations

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All Hyperlipoproteinemia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia
ClinicalTrials.gov ID: NCT01239992
Acronym / sponsor ID: KP-Niacin-2010
Conditions: Hyperlipoproteinemia, Metabolic Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: negative endpoint study resulting in withdrawal of study drug
Enrolment: 12 participants (actual)
Lead sponsor: Ludwig-Maximilians - University of MunichUniversity, hospital or other
Study start: Jun 2011
Primary completion: Jan 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 15 Nov 2010 (estimated)
Results: Posted 10 Apr 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Niacin/ Laropiprant	Experimental	Drug: Niacin/ Laropiprant

Who may qualify

Ages: 19 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male subjects or postmenopausal female subjects aged between 19-70 years
High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least simvastatin 20 mg/d
HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl
Lipoprotein (a) < 30 mg/dl
Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus.

Key exclusion criteria (13 listed)

Subjects with additional causes for hyperlipoproteinemia
Diabetes mellitus or antidiabetic medication
Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
History of psychiatric disorder or cognitive impairment that would interfere with participation in the study
History of alcoholism

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: Tredaptive, EU/1/08/459/0011000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily	Drug	Niacin/ Laropiprant

Primary outcome

Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test
Time frame: baseline and 12 weeks after treatment
Percent change of incremental AUC at 12 weeks compared to baseline.

2 secondary outcomes

HDL Cholesterol
Time frame: baseline and 12 weeks after treatment
Fasting Triglycerides
Time frame: baseline and 12 weeks after treatment

Results and safety

Results posted to the registry on 10 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Niacin/ Laropiprant	12	10

Primary outcome: Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test

Time frame: baseline and 12 weeks after treatment. Mean (Standard Deviation). Unit: percentage change

Measure	Niacin/ Laropiprant n = 10
Value	-28 (5)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Niacin/ Laropiprant	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperlipoproteinemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

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.

Klaus Parhofer, MD, Prof. principal investigator

Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Niacin/ Laropiprant in people with Hyperlipoproteinemia and Metabolic Syndrome, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2014). 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?

Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test (time frame: baseline and 12 weeks after treatment). 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 NCT01239992.

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 10 Apr 2014.