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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00705081
• Collaborator: (none)
• Enrollment: 453
• Duration (Months): 23

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. In addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: ezetimibe; Drug: statin

Detailed Description

Sampling method: invitation to the physician's patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 453 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study Evaluating the LDL-C Lowering Effects of Ezetimibe With a Statin as Prescribed in Daily Routine Practice in an Indonesian Population
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: ezetimibe; 10 mg once daily; Other Names: SCH 58235 ; Drug: statin
Previously treated with statin subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy	Drug: ezetimibe; 10 mg once daily; Other Names: SCH 58235 ; Drug: statin

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Adverse Events [4-6 weeks after the first visit]

   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.)

2. Intensity of Adverse Events Reported [4-6 weeks after the first visit]

   Intensity of adverse events reported after co-administration therapy

3. Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy [4-6 weeks after the first visit]

   Achievement of LDL-C target levels as determined by physician

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00705081
• Other Study ID Numbers: P04276
• First Posted: Jun 25, 2008
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Hypercholesterolemia; Ezetimibe

Study Results

Participant Flow

Arm/Group Title	Not Previously Treated	Previously Treated With Statin
Arm/Group Description	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	subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Period Title: Overall Study
STARTED	255	198
COMPLETED	255	198
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Not Previously Treated	Previously Treated With Statin	Total
Arm/Group Description	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	subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy	Total of all reporting groups
Overall Participants	255	198	453
Age, Customized (participants) [Number]
20-30 years	4 1.6%	1 0.5%	5 1.1%
31-40 years	21 8.2%	9 4.5%	30 6.6%
41-50 years	69 27.1%	57 28.8%	126 27.8%
51-60 years	108 42.4%	81 40.9%	189 41.7%
>61 years	53 20.8%	50 25.3%	103 22.7%
Sex: Female, Male (Count of Participants)
Female	106 41.6%	79 39.9%	185 40.8%
Male	149 58.4%	119 60.1%	268 59.2%
Region of Enrollment (participants) [Number]
Indonesia	255 100%	198 100%	453 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Adverse Events
Description	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.)
Time Frame	4-6 weeks after the first visit

Outcome Measure Data

Analysis Population Description

All participants enrolled

Arm/Group Title	Not Previously Treated	Previously Treated With Statin
Arm/Group Description	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	subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Measure Participants	255	198
Number [Participants]	1 0.4%	1 0.5%

2. Primary Outcome

Title	Intensity of Adverse Events Reported
Description	Intensity of adverse events reported after co-administration therapy
Time Frame	4-6 weeks after the first visit

Outcome Measure Data

Analysis Population Description

All participants enrolled

Arm/Group Title	Not Previously Treated	Previously Treated With Statin
Arm/Group Description	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	subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Measure Participants	255	198
Mild	1 0.4%	1 0.5%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%

3. Primary Outcome

Title	Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy
Description	Achievement of LDL-C target levels as determined by physician
Time Frame	4-6 weeks after the first visit

Outcome Measure Data

Analysis Population Description

All patients enrolled

Arm/Group Title	Not Previously Treated	Previously Treated With Statin
Arm/Group Description	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	subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Measure Participants	255	198
Number [Participants]	101 39.6%	106 53.5%

Adverse Events

Arm/Group Title	Not Previously Treated		Previously Treated With Statin
Arm/Group Description	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		subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
All Cause Mortality
	Not Previously Treated		Previously Treated With Statin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Not Previously Treated		Previously Treated With Statin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/255 (0%)		0/198 (0%)
Other (Not Including Serious) Adverse Events
	Not Previously Treated		Previously Treated With Statin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/255 (0%)		0/198 (0%)

Limitations/Caveats

Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.