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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date June 23, 2008
First Posted Date June 25, 2008
Results First Submitted Date March 26, 2009
Results First Posted Date August 3, 2009
Last Update Posted Date July 3, 2015
Study Start Date January 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2010)
  • Number of Participants Reporting Adverse Events [ Time Frame: 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.)
  • Intensity of Adverse Events Reported [ Time Frame: 4-6 weeks after the first visit ]
    Intensity of adverse events reported after co-administration therapy
  • Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy [ Time Frame: 4-6 weeks after the first visit ]
    Achievement of LDL-C target levels as determined by physician
Original Primary Outcome Measures
 (submitted: June 23, 2008)
Evaluation of the safety and tolerability of the LDL-C lowering [ Time Frame: 4-6 weeks after the first visit ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 23, 2008)
evaluation of the extent of LDL-C lowering relative to target levels [ Time Frame: 4-6 weeks after the first visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)
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
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.
Detailed Description Sampling method: invitation to the physician's patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population subjects with hypercholesterolemia
Condition Hypercholesterolemia
Intervention
  • Drug: ezetimibe
    10 mg once daily
    Other Name: SCH 58235
  • Drug: statin
Study Groups/Cohorts
  • 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
    Interventions:
    • Drug: ezetimibe
    • 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
    Interventions:
    • Drug: ezetimibe
    • Drug: statin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2009)
453
Original Actual Enrollment
 (submitted: June 23, 2008)
608
Actual Study Completion Date December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00705081
Other Study ID Numbers P04276
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor Merck Sharp & Dohme Corp.
Collaborators Not Provided
Investigators Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date June 2015