NCT00479388

Brief Summary

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,216

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 31, 2009

Completed
Last Updated

March 10, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

May 24, 2007

Results QC Date

June 9, 2009

Last Update Submit

February 20, 2015

Conditions

Primary HypercholesterolemiaMixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12

    Baseline and 12 Weeks

Secondary Outcomes (2)

  • Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12

    Baseline and 12 Weeks

  • Percent Change From Baseline in Triglycerides at Week 12

    Baseline and 12 Weeks

Study Arms (2)

1

OTHER

One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.

Drug: niacin (+) laropiprant

2

ACTIVE COMPARATOR

Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.

Drug: Comparator: simvastatinDrug: Comparator: atorvastatin calcium

Interventions

Comparator: simvastatinDRUG

simvastatin (20mg to 40mg) for 12 weeks.

Also known as: Zocor®
2
niacin (+) laropiprantDRUG

One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.

Also known as: MK0524A
1
Comparator: atorvastatin calciumDRUG

atorvastatin calcium (20mg to 40mg) for 12 weeks.

Also known as: atorvastatin
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
  • Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

You may not qualify if:

  • Patient whose LDL-C values are not within protocol specified range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Shah S, Ceska R, Gil-Extremera B, Paolini JF, Giezek H, Vandormael K, Mao A, McCrary Sisk C, Maccubbin D. Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2010 May;64(6):727-38. doi: 10.1111/j.1742-1241.2010.02370.x.

    PMID: 20518948RESULT

  • Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.

    PMID: 22500948DERIVED

  • Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.

    PMID: 21401833DERIVED

MeSH Terms

Interventions

SimvastatinNiacinMK-0524Atorvastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 28, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2008

Study Completion

October 1, 2008

Last Updated

March 10, 2015

Results First Posted

July 31, 2009

Record last verified: 2015-02