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

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ClinicalTrials.gov Identifier: NCT00705081
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : August 3, 2009
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hypercholesterolemia
Interventions Drug: ezetimibe
Drug: statin
Enrollment 453
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Not Previously Treated Previously Treated With Statin
Hide 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
Arm/Group Title Not Previously Treated Previously Treated With Statin Total
Hide 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 Number of Baseline Participants 255 198 453
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 255 participants 198 participants 453 participants
20-30 years 4 1 5
31-40 years 21 9 30
41-50 years 69 57 126
51-60 years 108 81 189
>61 years 53 50 103
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 198 participants 453 participants
Female
106
  41.6%
79
  39.9%
185
  40.8%
Male
149
  58.4%
119
  60.1%
268
  59.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Indonesia Number Analyzed 255 participants 198 participants 453 participants
255 198 453
1.Primary Outcome
Title Number of Participants Reporting Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled
Arm/Group Title Not Previously Treated Previously Treated With Statin
Hide 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
Overall Number of Participants Analyzed 255 198
Measure Type: Number
Unit of Measure: Participants
1 1
2.Primary Outcome
Title Intensity of Adverse Events Reported
Hide Description Intensity of adverse events reported after co-administration therapy
Time Frame 4-6 weeks after the first visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled
Arm/Group Title Not Previously Treated Previously Treated With Statin
Hide 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
Overall Number of Participants Analyzed 255 198
Measure Type: Number
Unit of Measure: Participants
Mild 1 1
Moderate 0 0
Severe 0 0
3.Primary Outcome
Title Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy
Hide Description Achievement of LDL-C target levels as determined by physician
Time Frame 4-6 weeks after the first visit
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled
Arm/Group Title Not Previously Treated Previously Treated With Statin
Hide 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
Overall Number of Participants Analyzed 255 198
Measure Type: Number
Unit of Measure: Participants
101 106
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Not Previously Treated Previously Treated With Statin
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Not Previously Treated Previously Treated With Statin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/255 (0.00%)   0/198 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Not Previously Treated Previously Treated With Statin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/255 (0.00%)   0/198 (0.00%) 
Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705081    
Other Study ID Numbers: P04276
First Submitted: June 23, 2008
First Posted: June 25, 2008
Results First Submitted: March 26, 2009
Results First Posted: August 3, 2009
Last Update Posted: July 3, 2015