Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia… (NCT01420549) | Clinical Trial Compass
CompletedPhase 3
Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia
Brazil129 participantsStarted 2013-03
Plain-language summary
The purpose of this study is to determine the non-inferiority between two different FDC (fixed-dose combination), measuring LDL-Cholesterol levels, in high risk patients with primary hypercholesterolemia or mixed dyslipidemia.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Male and female participants aged 18 to 80 years;
* Participants diagnosed with primary hypercholesterolemia or mixed dyslipidemia;
* Participants must not have other clinically significant comorbidities that may interfere with study evaluations;
* Participants able to understand and adhere to the therapeutic scheme and to attend the study visits;
* Participants who agree to maintain a low cholesterol diet throughout the study;
* Participants who agree to discontinue previous medication for hypercholesterolemia treatment throughout the study;
* Participants with hypercholesterolemia or mixed dyslipidemia with the following laboratory test results on the baseline visit: LDL-C level \>130 mg/dl if were receiving prior treatment with statins; or LDL-C level \>100 mg/dl if were receiving prior treatment with first generation statins; or LDL ≥160 mg/dL and ≤220 mg/dL and triglycerides ≤350 mg/dL if were not in prior treatment with statins.
* Female participants in reproductive age with negative serum beta-hCG test result in the baseline visit who agree to use acceptable contraceptive methods (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch, tubal ligation or female participants who declare to perform non reproductive sexual practices); except surgically sterile (for example oophorectomy and hysterectomy), surgical sterilization or of the partner; or postmenopausal for at least one …
What they're measuring
1
Reduction of LDL Cholesterol Levels
Timeframe: Baseline compared to the end of 9 weeks of treatment