NCT00652444

Brief Summary

The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_4

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

September 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

March 31, 2008

Last Update Submit

February 7, 2022

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Percentage reduction of LDL-C after 6 weeks of treatment.

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Coadministration arm: simvastatin 20mg and ezetimibe 10mg

Drug: ezetimibeDrug: simvastatin

2

EXPERIMENTAL

Monotherapy arm: simvastatin 20mg and ezetimibe placebo

Drug: simvastatinDrug: Placebo (Unspecified)

Interventions

ezetimibeDRUG

ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.

Also known as: Zetia®, EZETROL®, MK0653
1
simvastatinDRUG

simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.

Also known as: Zocor®, MK0733
12
Placebo (Unspecified)DRUG

Matching ezetimibe placebo

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
  • Age of at least 18 years and 75 years or less
  • Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l

You may not qualify if:

  • Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
  • Uncontrolled cardiac arrhythmias
  • Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
  • History of unstable or severe peripheral artery disease within 3 months of study entry
  • Uncontrolled hypertension at study entry
  • Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
  • Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function
  • Active or chronic hepatic and hepatobiliary disease
  • Disorders that would limit study evaluation or participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.

    PMID: 18545068BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

EzetimibeSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 3, 2008

Study Start

September 1, 2003

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

February 18, 2022

Record last verified: 2022-02