NCT00423579

The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)

Completed Phase 4 Results posted Last updated 22 May 2024

What this trial tests

Phase 4 trial testing Ezetimibe/Simvastatin 10/20 mg in Hypercholesterolemia in 120 participants. Completed in 1 March 2008.

Timeline

1 July 2006

Primary endpoint
1 March 2008

1 March 2008

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	1 July 2006
Primary completion	1 March 2008
Estimated completion	1 March 2008

Drugs / interventions tested

• Ezetimibe/Simvastatin 10/20 mg — full drug profile →
• simvastatin 40 mg — full drug profile →

Conditions studied

• Hypercholesterolemia — all drugs for Hypercholesterolemia →
• Coronary Disease — all drugs for Coronary Disease →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 18 to 75, any sex, with Hypercholesterolemia or Coronary Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks Primary · Baseline and 6 weeks

Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment.

Group	Value	95% CI
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	-26.5	± 9.5
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg	-11.9	± 13.6

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo

Serious: 0/60 (0%)

Deaths: —

Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg

Serious: 1/60 (2%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Ezetimibe/Simvastatin 10/2…	Ezetimibe/Simvastatin Plac…
Transient Ischemic Attack	Cardiac disorders	—	—

Most-reported serious reactions: Transient Ischemic Attack.

Data from ClinicalTrials.gov NCT00423579 adverse events section.

Sponsor's own description

This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ezetimibe/simvastatin 10/20 mg versus simvastatin 40 mg in coronary heart disease patients.
   Averna M, Zaninelli A, Le Grazie C, Gensini GF. · · 2010 · cited 9× · PMID 21122660 · DOI 10.1016/j.jacl.2010.05.002
2. Ezetimibe/simvastatin vs simvastatin in coronary heart disease patients with or without diabetes.
   Rotella CM, Zaninelli A, Le Grazie C, Hanson ME, et al · · 2010 · cited 9× · PMID 20663203 · DOI 10.1186/1476-511x-9-80