Trial Outcomes & Findings for Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457) (NCT NCT00653523)
NCT ID: NCT00653523
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 treatment-related was considered an adverse reaction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
151 participants
Primary outcome timeframe
Throughout 1 year of study
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Ezetimibe + Simvastatin
Ezetimibe 10 mg + Simvastatin 20 mg
1. level below what was specified in inclusion criterion
2. level \>2x upper limit of normal at start of treatment
3. level \>=3x upper limit of normal after start of treatment
4. did not resolve or improve after dose reduction of simvastatin
|
|---|---|
|
Overall Study
STARTED
|
151
|
|
Overall Study
COMPLETED
|
132
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Ezetimibe + Simvastatin
Ezetimibe 10 mg + Simvastatin 20 mg
1. level below what was specified in inclusion criterion
2. level \>2x upper limit of normal at start of treatment
3. level \>=3x upper limit of normal after start of treatment
4. did not resolve or improve after dose reduction of simvastatin
|
|---|---|
|
Overall Study
Drop in low density lipoprotein (1)
|
2
|
|
Overall Study
Elevated creatine phosphokinase (2)
|
1
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Elevated alanine aminotransferase (3)
|
2
|
|
Overall Study
Adverse reaction did not improve (4)
|
1
|
Baseline Characteristics
Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Baseline characteristics by cohort
| Measure |
Ezetimibe + Simvastatin
n=151 Participants
Ezetimibe 10 mg + Simvastatin 20 mg
|
|---|---|
|
Age, Customized
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
151 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 treatment-related was considered an adverse reaction.
Outcome measures
| Measure |
Ezetimibe + Simvastatin
n=151 Participants
Ezetimibe 10 mg + Simvastatin 20 mg
|
|---|---|
|
Number of Participants With Adverse Events and Adverse Reactions
Adverse Events
|
143 Participants
|
|
Number of Participants With Adverse Events and Adverse Reactions
Adverse Reactions
|
36 Participants
|
Adverse Events
Ezetimibe+Simvastatin
Serious events: 17 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe+Simvastatin
n=151 participants at risk
|
|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.66%
1/151 • Number of events 1
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.66%
1/151 • Number of events 1
|
|
Cardiac disorders
HYPERTROPHIC CARDIOMYOPATHY
|
0.66%
1/151 • Number of events 1
|
|
Eye disorders
EYE PAIN
|
0.66%
1/151 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.66%
1/151 • Number of events 1
|
|
Injury, poisoning and procedural complications
CORONARY ARTERY RESTENOSIS
|
2.0%
3/151 • Number of events 3
|
|
Injury, poisoning and procedural complications
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.66%
1/151 • Number of events 2
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.66%
1/151 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.66%
1/151 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.66%
1/151 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.66%
1/151 • Number of events 1
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.66%
1/151 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.66%
1/151 • Number of events 1
|
|
Surgical and medical procedures
ARTERIAL STENT INSERTION
|
0.66%
1/151 • Number of events 2
|
|
Vascular disorders
AORTIC DISSECTION
|
0.66%
1/151 • Number of events 1
|
Other adverse events
| Measure |
Ezetimibe+Simvastatin
n=151 participants at risk
|
|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
6.0%
9/151 • Number of events 9
|
|
Infections and infestations
BRONCHITIS
|
13.2%
20/151 • Number of events 25
|
|
Infections and infestations
NASOPHARYNGITIS
|
30.5%
46/151 • Number of events 73
|
|
Infections and infestations
PHARYNGITIS
|
6.6%
10/151 • Number of events 13
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
17.2%
26/151 • Number of events 32
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.6%
10/151 • Number of events 11
|
|
Investigations
BLOOD AMYLASE INCREASED
|
7.9%
12/151 • Number of events 14
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
17.9%
27/151 • Number of events 33
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
27.2%
41/151 • Number of events 47
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
9.3%
14/151 • Number of events 14
|
|
Investigations
GLYCOSYLATED HAEMOGLOBIN INCREASED
|
6.6%
10/151 • Number of events 11
|
|
Investigations
MYOGLOBIN BLOOD INCREASED
|
13.9%
21/151 • Number of events 21
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
7.9%
12/151 • Number of events 12
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
5.3%
8/151 • Number of events 8
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
6.0%
9/151 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.9%
15/151 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.3%
17/151 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
9.3%
14/151 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
8.6%
13/151 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.3%
11/151 • Number of events 12
|
|
Nervous system disorders
HEADACHE
|
7.9%
12/151 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
7.3%
11/151 • Number of events 13
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
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