CClinicalTrials.gg
Sign In
CompletedNCT00652444Updated Feb 18, 2022

Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

A Phase 4 interventional study of ezetimibe and simvastatin in Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Organon and Co · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 120 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    1

    Coadministration arm: simvastatin 20mg and ezetimibe 10mg

    Drug: ezetimibe · Drug: simvastatin

  • Experimental
    2

    Monotherapy arm: simvastatin 20mg and ezetimibe placebo

    Drug: simvastatin · Drug: Placebo (Unspecified)

Interventions

  • Drugezetimibe

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

    Also known as: Zetia®, EZETROL®, MK0653

  • Drugsimvastatin

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

    Also known as: Zocor®, MK0733

  • DrugPlacebo (Unspecified)

    Matching ezetimibe placebo

06

What researchers measure

Primary outcomes

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

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18545068 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00652444
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Apr 3, 2008
Start date
Sep 2003
Primary completion
Aug 2004
Completion
Aug 2004
Last update
Feb 18, 2022

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypercholesterolemia→

Other studies from this sponsor

Organon and Co

Start the discussion