MedTrace Logo

To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

NCT00271817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2024-05-16

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

DRUG

Comparator: ezetimibe/simvastatin + niacin (ER)

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

DRUG

Comparator: Placebo to ezetimibe/simvastatin

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

DRUG

Comparator: niacin (ER) tablet

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

DRUG

Comparator: ezetimibe (+) simvastatin

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

DRUG

Comparator: Placebo to Niacin (ER)

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

DRUG

Comparator: ezetimibe/simvastatin and niacin (ER)

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

DRUG

Comparator: ezetimibe and simvastatin

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

DRUG

Comparator: Placebo to niacin (ER)

Niacin (ER) (Pbo) tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-02-29
Completion
2008-02-29

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00271817 on ClinicalTrials.gov