NCT00654095

Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)

Completed Phase 3 Results posted Last updated 21 May 2024

What this trial tests

Phase 3 trial testing Ezetimibe in Hypercholesterolemia in 146 participants. Completed in 1 June 2009.

Timeline

1 December 2007

Primary endpoint
1 June 2009

1 June 2009

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	146
Start date	1 December 2007
Primary completion	1 June 2009
Estimated completion	1 June 2009

Drugs / interventions tested

• Ezetimibe (EZETIMIBE) — full drug profile →
• atorvastatin (atorvastatin) — full drug profile →

Conditions studied

• Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

Organon and Co — full company profile →

Who can join

20 and older, any sex, with 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.

Number of Participants With Adverse Events and Adverse Reactions Primary · Throughout 1 year of study

An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified. That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered. Any adverse event that was considered treatment-related was considered an adverse reaction.

Adverse Events

Group	Value	95% CI
Ezetimibe + Atorvastatin	141

Adverse Reactions

Group	Value	95% CI
Ezetimibe + Atorvastatin	61

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: 11/146 (8%)

Deaths: —

Serious adverse events (15 terms)

Reaction	System	Ezetimibe+Atorvastatin
SICK SINUS SYNDROME	Cardiac disorders	—
GLAUCOMA	Eye disorders	—
RETINAL ARTERY OCCLUSION	Eye disorders	—
GASTROENTERITIS	Infections and infestations	—
HUMERUS FRACTURE	Injury, poisoning and procedural complications	—
IN-STENT CORONARY ARTERY RESTENOSIS	Injury, poisoning and procedural complications	—
RIB FRACTURE	Injury, poisoning and procedural complications	—
ULNA FRACTURE	Injury, poisoning and procedural complications	—
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
PANCREATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
CEREBRAL HAEMORRHAGE	Nervous system disorders	—
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	—
ERYTHEMA MULTIFORME	Skin and subcutaneous tissue disorders	—

Other adverse events (26 terms — click to expand)

Reaction	System	Ezetimibe+Atorvastatin
NASOPHARYNGITIS	Infections and infestations	—
ALANINE AMINOTRANSFERASE INCREASED	Investigations	—
C-REACTIVE PROTEIN INCREASED	Investigations	—
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	—
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	—
BILIRUBIN CONJUGATED INCREASED	Investigations	—
UPPER RESPIRATORY TRACT INFLAMMATION	Respiratory, thoracic and mediastinal disorders	—
MYOGLOBIN BLOOD INCREASED	Investigations	—
MYOGLOBIN URINE PRESENT	Investigations	—
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—
BRONCHITIS	Infections and infestations	—
BLOOD BILIRUBIN INCREASED	Investigations	—
WHITE BLOOD CELL COUNT INCREASED	Investigations	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—
CONSTIPATION	Gastrointestinal disorders	—
GASTRITIS	Gastrointestinal disorders	—
MALAISE	General disorders	—
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	—
GASTROENTERITIS	Infections and infestations	—
GLYCOSYLATED HAEMOGLOBIN INCREASED	Investigations	—
WEIGHT INCREASED	Investigations	—
SEASONAL ALLERGY	Immune system disorders	—
PHARYNGITIS	Infections and infestations	—
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	—
HEADACHE	Nervous system disorders	—

Most-reported serious reactions: SICK SINUS SYNDROME, GLAUCOMA, RETINAL ARTERY OCCLUSION, GASTROENTERITIS, HUMERUS FRACTURE, IN-STENT CORONARY ARTERY RESTENOSIS, RIB FRACTURE, ULNA FRACTURE.

Data from ClinicalTrials.gov NCT00654095 adverse events section.

Sponsor's own description

Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.