Trial Outcomes & Findings for Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456) (NCT NCT00654095)
NCT ID: NCT00654095
Last Updated: 2024-05-21
Results Overview
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.
COMPLETED
PHASE3
146 participants
Throughout 1 year of study
2024-05-21
Participant Flow
Participants did not Complete the Study: 1. level below what was specified in inclusion criterion 2. level \>500 mg/dL at start of treatment 3. level \>2x upper limit of normal at start of treatment 4. level \>=3x upper limit of normal after start of treatment 5. Adverse reactions did not improve or resolve after dose reduction of atorvastatin
Participant milestones
| Measure |
Ezetimibe + Atorvastatin
Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
|
|---|---|
|
Overall Study
STARTED
|
146
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Ezetimibe + Atorvastatin
Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
|
|---|---|
|
Overall Study
Drop in low density lipoprotein (1)
|
2
|
|
Overall Study
Elevated triglyceride level (2)
|
1
|
|
Overall Study
Elevated alanine aminotransferase (3)
|
1
|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Elevated alanine aminotransferase (4)
|
7
|
|
Overall Study
Adverse reaction did not improve (5)
|
4
|
|
Overall Study
Did not meet inclusion criteria
|
1
|
Baseline Characteristics
Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
Baseline characteristics by cohort
| Measure |
Ezetimibe + Atorvastatin
n=146 Participants
Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
|
|---|---|
|
Age, Customized
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
146 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout 1 year of studyAn 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.
Outcome measures
| Measure |
Ezetimibe + Atorvastatin
n=146 Participants
Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
|
|---|---|
|
Number of Participants With Adverse Events and Adverse Reactions
Adverse Events
|
141 Participants
|
|
Number of Participants With Adverse Events and Adverse Reactions
Adverse Reactions
|
61 Participants
|
Adverse Events
Ezetimibe+Atorvastatin
Serious adverse events
| Measure |
Ezetimibe+Atorvastatin
n=146 participants at risk
|
|---|---|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.68%
1/146 • Number of events 1
|
|
Eye disorders
GLAUCOMA
|
0.68%
1/146 • Number of events 1
|
|
Eye disorders
RETINAL ARTERY OCCLUSION
|
0.68%
1/146 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
0.68%
1/146 • Number of events 1
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.68%
1/146 • Number of events 1
|
|
Injury, poisoning and procedural complications
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.68%
1/146 • Number of events 1
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.68%
1/146 • Number of events 1
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.68%
1/146 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.68%
1/146 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.68%
1/146 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC NEOPLASM
|
0.68%
1/146 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.68%
1/146 • Number of events 1
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.68%
1/146 • Number of events 1
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.68%
1/146 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.68%
1/146 • Number of events 1
|
Other adverse events
| Measure |
Ezetimibe+Atorvastatin
n=146 participants at risk
|
|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
6.8%
10/146 • Number of events 10
|
|
Gastrointestinal disorders
GASTRITIS
|
6.8%
10/146 • Number of events 11
|
|
General disorders
MALAISE
|
6.8%
10/146 • Number of events 16
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.5%
8/146 • Number of events 9
|
|
Infections and infestations
BRONCHITIS
|
7.5%
11/146 • Number of events 11
|
|
Infections and infestations
GASTROENTERITIS
|
6.2%
9/146 • Number of events 11
|
|
Infections and infestations
NASOPHARYNGITIS
|
36.3%
53/146 • Number of events 97
|
|
Infections and infestations
PHARYNGITIS
|
5.5%
8/146 • Number of events 12
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
32.9%
48/146 • Number of events 59
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
11.0%
16/146 • Number of events 18
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
12.3%
18/146 • Number of events 26
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
7.5%
11/146 • Number of events 16
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
13.7%
20/146 • Number of events 24
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
21.2%
31/146 • Number of events 39
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
16.4%
24/146 • Number of events 26
|
|
Investigations
GLYCOSYLATED HAEMOGLOBIN INCREASED
|
6.2%
9/146 • Number of events 9
|
|
Investigations
MYOGLOBIN BLOOD INCREASED
|
11.6%
17/146 • Number of events 23
|
|
Investigations
MYOGLOBIN URINE PRESENT
|
11.6%
17/146 • Number of events 18
|
|
Investigations
WEIGHT INCREASED
|
6.2%
9/146 • Number of events 9
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
7.5%
11/146 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.5%
11/146 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.2%
12/146 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
5.5%
8/146 • Number of events 8
|
|
Nervous system disorders
HEADACHE
|
5.5%
8/146 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
6.8%
10/146 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
12.3%
18/146 • Number of events 23
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator (PI) agrees, for a period of 5 years following the Effective Date, to retain the Disclosure made to it by or on behalf of Sponsor (SPKK), in confidence and not to disclose it to any third party. PI further agrees that during such time period it will not, either directly or indirectly, use the Disclosure for any purpose(s) other than that indicated herein without the prior written consent of SPKK.
- Publication restrictions are in place
Restriction type: OTHER