Trials / Completed
CompletedNCT00783263
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Comparator: rosuvastatin 5 mg + ezetimibe 10 mg | Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. |
| DRUG | Comparator: rosuvastatin 10 mg | Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks. |
| DRUG | Comparator: rosuvastatin 10 mg + ezetimibe 10 mg | Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks. |
| DRUG | Comparator: rosuvastatin 20 mg | Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks. |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2010-05-01
- Completion
- 2010-05-01
- First posted
- 2008-10-31
- Last updated
- 2024-05-14
- Results posted
- 2011-09-14
Source: ClinicalTrials.gov record NCT00783263. Inclusion in this directory is not an endorsement.