NCT00271817

Brief Summary

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,220

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2005

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

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 3, 2009

Completed
Last Updated

May 16, 2024

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

January 3, 2006

Results QC Date

February 13, 2009

Last Update Submit

May 8, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

  • Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

    Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline

    Baseline and 24 Weeks

  • Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline

    Baseline and 24 weeks

Secondary Outcomes (8)

  • Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

    Baseline and 24 weeks

  • Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)

    Baseline and 24 weeks

  • Percent Change From Baseline in Triglycerides (TG)

    baseline and 24 Weeks

  • Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)

    Baseline and 64 weeks

  • Percent Change From Baseline in Triglycerides (TG)

    Baseline and 64 weeks

  • +3 more secondary outcomes

Study Arms (5)

Part 1 - Arm 1

ACTIVE COMPARATOR

ezetimibe/simvastatin combination tablet + niacin (ER)

Drug: Comparator: ezetimibe/simvastatin + niacin (ER)

Part 1 -Arm 2

ACTIVE COMPARATOR

ezetimibe/simvastatin

Drug: Comparator: ezetimibe (+) simvastatinDrug: Comparator: Placebo to Niacin (ER)

Part 1 - Arm 3

ACTIVE COMPARATOR

Niacin (ER)

Drug: Comparator: Placebo to ezetimibe/simvastatinDrug: Comparator: niacin (ER) tablet

Part 2 - Arm 1

ACTIVE COMPARATOR

ezetimibe/simvastatin combination tablet + niacin (ER)

Drug: Comparator: ezetimibe/simvastatin and niacin (ER)

Part 2 - Arm 2

PLACEBO COMPARATOR

ezetimibe/simvastatin combination tablet + niacin (Pbo)

Drug: Comparator: ezetimibe and simvastatinDrug: Comparator: Placebo to niacin (ER)

Interventions

Comparator: ezetimibe/simvastatin + niacin (ER)DRUG

ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks

Part 1 - Arm 1
Comparator: Placebo to ezetimibe/simvastatinDRUG

ezetimibe/simvastatin (Pbo) tablet. Treatment time will be \~24 weeks.

Part 1 - Arm 3
Comparator: niacin (ER) tabletDRUG

niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks

Part 1 - Arm 3
Comparator: ezetimibe (+) simvastatinDRUG

ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~24 weeks.

Part 1 -Arm 2
Comparator: Placebo to niacin (ER)DRUG

Niacin (ER) (Pbo) tablet. Treatment time will be \~24 weeks.

Part 1 -Arm 2
Comparator: ezetimibe/simvastatin and niacin (ER)DRUG

ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be \~40 additional weeks for a total of 64 weeks

Part 2 - Arm 1
Comparator: ezetimibe and simvastatinDRUG

ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks

Part 2 - Arm 2

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
  • Patient willing to be on a low-cholesterol diet

You may not qualify if:

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
  • Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
  • Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Guyton JR, Brown BG, Fazio S, Polis A, Tomassini JE, Tershakovec AM. Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. J Am Coll Cardiol. 2008 Apr 22;51(16):1564-72. doi: 10.1016/j.jacc.2008.03.003.

    PMID: 18420099BACKGROUND

  • Le NA, Jin R, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Changes in lipoprotein particle number with ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidemic patients. J Am Heart Assoc. 2013 Aug 7;2(4):e000037. doi: 10.1161/JAHA.113.000037.

    PMID: 23926117DERIVED

  • Guyton JR, Fazio S, Adewale AJ, Jensen E, Tomassini JE, Shah A, Tershakovec AM. Effect of extended-release niacin on new-onset diabetes among hyperlipidemic patients treated with ezetimibe/simvastatin in a randomized controlled trial. Diabetes Care. 2012 Apr;35(4):857-60. doi: 10.2337/dc11-1369. Epub 2012 Feb 14.

    PMID: 22338103DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

SimvastatinNiacinTablets

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingDosage FormsPharmaceutical Preparations

Limitations and Caveats

Part 1 population is all patients enrolled in Part 1 of the study. Part 2 is those patients who received either niacin, ezetimibe/simvastatin, or ezetimibe/simvastatin + niacin during Part 1 until they finished the study at week 64 or discontinued.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
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

January 3, 2006

First Posted

January 4, 2006

Study Start

December 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

May 16, 2024

Results First Posted

August 3, 2009

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share