NCT00871351

Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

Completed Phase 4 Results posted Last updated 23 May 2024

What this trial tests

Phase 4 trial testing Ezetimibe in Primary Hypercholesterolemia in 125 participants. Completed in 1 May 2010.

Timeline

1 February 2009

Primary endpoint
1 May 2010

1 May 2010

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	125
Start date	1 February 2009
Primary completion	1 May 2010
Estimated completion	1 May 2010

Drugs / interventions tested

• Ezetimibe (EZETIMIBE) — full drug profile →
• Atorvastatin (atorvastatin) — full drug profile →
• Atorvastatin (atorvastatin) — full drug profile →
• Rosuvastatin (rosuvastatin) — full drug profile →

Conditions studied

• Primary Hypercholesterolemia — all drugs for Primary Hypercholesterolemia →

Sponsor

Organon and Co — full company profile →

Who can join

20 and older, any sex, with Primary Hypercholesterolemia. 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.

Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values Primary · End of Week 4 to Week 16 or discontinuation

LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).

Group	Value	95% CI
Ezetimibe + Atorvastatin	-25.8	-29.2 – -22.4
Atorvastatin	-15.1	-18.6 – -11.7
Rosuvastatin	0.8	-3.3 – 4.9

Percent Change in LDL-C Secondary · End of washout period to Week 16 or discontinuation

LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).

Group	Value	95% CI
Ezetimibe + Atorvastatin	-49.6	-52.9 – -46.4
Atorvastatin	-41.1	-44.4 – -37.9
Rosuvastatin	-30.5	-34.4 – -26.6

Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values Secondary · Week 16 or discontinuation

LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation). Target values: For participants with history of coronary artery disease: \<100 mg/dL; for participants with at least 3 cardiovascular (CV) risk factors: \<120 mg/dL; for participants with 1-2 CV risk factors: \<140 mg/dL; for participants with no CV risk factors: \<160 mg/dL.

Group	Value	95% CI
Ezetimibe + Atorvastatin	37
Atorvastatin	19
Rosuvastatin	1

Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP) Secondary · End of Week 4 to Week 16 or discontinuation

Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.

Total Cholesterol

Group	Value	95% CI
Ezetimibe + Atorvastatin	-18.0	-20.7 – -15.2
Atorvastatin	-10.3	-13.1 – -7.4
Rosuvastatin	1.9	-1.7 – 5.5

Triglycerides

Group	Value	95% CI
Ezetimibe + Atorvastatin	-0.8	-14.4 – 12.8
Atorvastatin	0.2	-10.9 – 11.4
Rosuvastatin	14.7	2.3 – 27.0

High-Density Lipoprotein Cholesterol (HDL-C)

Group	Value	95% CI
Ezetimibe + Atorvastatin	4.5	0.9 – 8.2
Atorvastatin	0.5	-2.6 – 3.5
Rosuvastatin	2.5	-1.4 – 6.4

Non-HDL-C

Group	Value	95% CI
Ezetimibe + Atorvastatin	-25.0	-28.5 – -21.5
Atorvastatin	-13.7	-17.0 – -10.3
Rosuvastatin	2.0	-2.6 – 6.5

High Sensitivity C-Reactive Protein (Hs-CRP)

Group	Value	95% CI
Ezetimibe + Atorvastatin	49.0	-43.2 – 141.3
Atorvastatin	9.9	-24.1 – 43.9
Rosuvastatin	25.7	-4.8 – 56.1

Percent Change in Total Lipids and Hs-CRP Secondary · End of washout to Week 16 or discontinuation

Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).

Total Cholesterol

Group	Value	95% CI
Ezetimibe + Atorvastatin	-39.9	-42.1 – -37.7
Atorvastatin	-32.8	-35.8 – -29.7
Rosuvastatin	-24.4	-27.9 – -21.0

Triglycerides

Group	Value	95% CI
Ezetimibe + Atorvastatin	-25.3	-36.0 – -14.6
Atorvastatin	-18.8	-29.8 – -7.8
Rosuvastatin	-12.0	-21.3 – -2.7

High-Density Lipoprotein Cholesterol (HDL-C)

Group	Value	95% CI
Ezetimibe + Atorvastatin	10.3	6.1 – 14.5
Atorvastatin	7.4	3.7 – 11.0
Rosuvastatin	9.9	3.6 – 16.2

Non-HDL-C

Group	Value	95% CI
Ezetimibe + Atorvastatin	-50.1	-52.7 – -47.6
Atorvastatin	-41.4	-44.8 – -37.9
Rosuvastatin	-31.3	-35.4 – -27.1

High Sensitivity C-reactive Protein (Hs-CRP)

Group	Value	95% CI
Ezetimibe + Atorvastatin	73.0	-84.4 – 230.4
Atorvastatin	-2.9	-36.3 – 30.4
Rosuvastatin	-13.6	-39.7 – 12.6

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 + Atorvastatin

Serious: 4/47 (9%)

Deaths: —

Atorvastatin

Serious: 1/46 (2%)

Deaths: —

Rosuvastatin

Serious: 0/32 (0%)

Deaths: —

Serious adverse events (5 terms)

Reaction	System	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
Chest discomfort	General disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Heat illness	Injury, poisoning and procedural complications	—	—	—
Carcinoid tumour of the gastrointestinal tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
Nasopharyngitis	Infections and infestations	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—
Headache	Nervous system disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—

Most-reported serious reactions: Chest discomfort, Pneumonia, Heat illness, Carcinoid tumour of the gastrointestinal tract, Rectal cancer.

Data from ClinicalTrials.gov NCT00871351 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia-Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia.
   Teramoto T, Sawada T, Iwamoto K, Daida H. · · 2012 · cited 9× · PMID 24653510 · DOI 10.1016/j.curtheres.2012.02.002