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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Hypercholesterolemia |
| Interventions: |
Drug: Ezetimibe Drug: Simvastatin |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| Description | |
|---|---|
| Ezetimibe + Simvastatin |
Ezetimibe 10 mg + Simvastatin 20 mg
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| Ezetimibe + Simvastatin | |
|---|---|
| STARTED | 151 |
| COMPLETED | 132 |
| NOT COMPLETED | 19 |
| Drop in low density lipoprotein (1) | 2 |
| Elevated creatine phosphokinase (2) | 1 |
| Adverse Event | 7 |
| Withdrawal by Subject | 6 |
| Elevated alanine aminotransferase (3) | 2 |
| Adverse reaction did not improve (4) | 1 |
Baseline Characteristics
| Description | |
|---|---|
| Ezetimibe + Simvastatin | Ezetimibe 10 mg + Simvastatin 20 mg |
| Ezetimibe + Simvastatin | |
|---|---|
|
Number of Participants
[units: participants] |
151 |
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Age, Customized
[1] [units: Participants] |
151 |
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Gender
[units: participants] |
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| Female | 82 |
| Male | 69 |
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Region of Enrollment
[units: participants] |
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| Japan | 151 |
| [1] | Age 20 years and older |
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Outcome Measures
More Information
| 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. | ||||||
The agreement is:
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| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00653523 History of Changes |
| Other Study ID Numbers: | P05457 |
| Study First Received: | April 1, 2008 |
| Results First Received: | May 27, 2010 |
| Last Updated: | August 12, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |