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

May 8, 2024 updated by: Organon and Co

Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1220

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Part 1 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
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
Active Comparator: Part 1 -Arm 2
ezetimibe/simvastatin
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.
Active Comparator: Part 1 - Arm 3
Niacin (ER)
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
Active Comparator: Part 2 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
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
Placebo Comparator: Part 2 - Arm 2
ezetimibe/simvastatin combination tablet + niacin (Pbo)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time Frame: Baseline and 24 Weeks
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)
Time Frame: Baseline and 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Time Frame: Baseline and 24 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
Baseline and 24 weeks
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Time Frame: Baseline and 24 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline
Baseline and 24 weeks
Percent Change From Baseline in Triglycerides (TG)
Time Frame: baseline and 24 Weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline
baseline and 24 Weeks
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Time Frame: Baseline and 64 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline
Baseline and 64 weeks
Percent Change From Baseline in Triglycerides (TG)
Time Frame: Baseline and 64 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline
Baseline and 64 weeks
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Time Frame: Baseline and 64 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline
Baseline and 64 weeks
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time Frame: Baseline and 64 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline
Baseline and 64 weeks
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Time Frame: Baseline and 24 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
Baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria

January 3, 2006

First Posted (Estimated)

January 4, 2006

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653A-091
  • 2005_091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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