Trial Outcomes & Findings for Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED) (NCT NCT00705081)

Results Overview

Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)

Recruitment status

COMPLETED

Target enrollment

453 participants

Primary outcome timeframe

4-6 weeks after the first visit

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Not Previously Treated subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy	Previously Treated With Statin subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Overall Study STARTED	255	198
Overall Study COMPLETED	255	198
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Not Previously Treated n=255 Participants subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy	Previously Treated With Statin n=198 Participants subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy	Total n=453 Participants Total of all reporting groups
Age, Customized 20-30 years	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Age, Customized 31-40 years	21 participants n=5 Participants	9 participants n=7 Participants	30 participants n=5 Participants
Age, Customized 41-50 years	69 participants n=5 Participants	57 participants n=7 Participants	126 participants n=5 Participants
Age, Customized 51-60 years	108 participants n=5 Participants	81 participants n=7 Participants	189 participants n=5 Participants
Age, Customized >61 years	53 participants n=5 Participants	50 participants n=7 Participants	103 participants n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	79 Participants n=7 Participants	185 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants	119 Participants n=7 Participants	268 Participants n=5 Participants
Region of Enrollment Indonesia	255 participants n=5 Participants	198 participants n=7 Participants	453 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 weeks after the first visit

Population: All participants enrolled

Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)

Outcome measures

Outcome measures
Measure	Not Previously Treated n=255 Participants subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy	Previously Treated With Statin n=198 Participants subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Number of Participants Reporting Adverse Events	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 4-6 weeks after the first visit

Population: All participants enrolled

Intensity of adverse events reported after co-administration therapy

Outcome measures

Outcome measures
Measure	Not Previously Treated n=255 Participants subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy	Previously Treated With Statin n=198 Participants subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Intensity of Adverse Events Reported Mild	1 Participants	1 Participants
Intensity of Adverse Events Reported Moderate	0 Participants	0 Participants
Intensity of Adverse Events Reported Severe	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 4-6 weeks after the first visit

Population: All patients enrolled

Achievement of LDL-C target levels as determined by physician

Outcome measures

Outcome measures
Measure	Not Previously Treated n=255 Participants subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy	Previously Treated With Statin n=198 Participants subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy	101 Participants	106 Participants

Adverse Events

Not Previously Treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Previously Treated With Statin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60