Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets
- Conditions
- Hypertension, Hyperlipidemia
- Interventions
- Drug: Ezetimibe/Rosuvastatin
- Registration Number
- NCT03847506
- Lead Sponsor
- HK inno.N Corporation
- Brief Summary
To evaluate the efficacy and the safety of concomitant use of Ezetimibe/Rosuvastatin combination tablets and Candesartan cilexetil/Amlodipine besylate combination tablets compared to each combination tablet alone in patients with essential hypertension (HTN) and hyperlipidemia.
- Detailed Description
To improve the ease of use of high blood pressure and hyperlipidemia to improve patient compliance and reduce the risk of cardiovascular disease.
And It is recommended to identify the need to develop a combination of Candesartan cilexetil/Amlodipine besylate combination tablets , and Ezetimibe/Rosuvastatin combination tablets.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EZE/ROS+CAN/AML Ezetimibe/Rosuvastatin Ezetimibe/Rosuvastatin 10 mg/10 mg and Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg, once a day for 6 weeks CAN/AML Candesartan cilexetil/Amlodipine besylate Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg, once a day for 6 weeks EZE/ROS+CAN Candesartan cilexetil Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil 8 mg, once a day for 6 weeks
- Primary Outcome Measures
Name Time Method Percentage change in LDL-C levels from baseline after 6 weeks of study treatment week 6 EZE/ROS + CAN/AML arm vs. CAN/AML arm
Percentage change in LDL-C levels from baseline after 6 weeks of study treatment For the percentage change in LDL-C levels at baseline and after 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage change in baseline-adjusted LDL-C levels from baseline after 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with percentage change in LDL-C levels as response variable and baseline LDL-C level and treatment arm as independent variables.Change in sitting Systolic Blood Pressure(siSBP) from baseline after 6 weeks of study treatment week 6 EZE/ROS + CAN/AML arm vs. EZE/ROS + CAN arm
Change in siSBP from baseline after 6 weeks of study treatment For the siSBP at baseline and after 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siSBP from baseline after 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the analysis of covariance (ANCOVA) with change in siSBP as response variable and baseline siSBP and treatment arm as independent variables.
- Secondary Outcome Measures
Name Time Method Percentage changes in LDL-C levels from baseline after 3 and 6 weeks of study treatment week 3 and week 6 EZE/ROS + CAN/AML arm vs. EZE/ROS + CAN arm
For the LDL-C levels at baseline and after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage changes in baseline-adjusted LDL-C levels from baseline after 3 and 6 weeks of study treatment and their standard error will be provided by treatment arm. Inter-arm comparisons of the percentage changes in LDL-C levels at Week 3 and Week 6 will be conducted using the ANCOVA with percentage change in LDL-C levels as response variable and baseline LDL-C level and treatment arm as independent variables.Proportions of subjects who achieve the treatment goal based on NCEP ATP III Guideline from baseline after 3 and 6 weeks of study treatment week 3 and week 6 Co-Endpoints
(LDL-C treatment goal - Group I: \<160 mg/dL; Group II: \<130 mg/dL; and Group III: \<100 mg/dL) The frequencies and proportions of subjects who achieve the treatment goal based on NCEP ATP III Guideline from baseline after 3 and 6 weeks of study treatment will be provided by treatment arm. The differences in the proportions of subjects who achieve the treatment goal after 3 and 6 weeks of study treatment between treatment arms will be analyzed using the Pearson's chi-square test or the Fisher's exact test.Percentage change in LDL-C levels from baseline after 3 weeks of study treatment week 3 EZE/ROS + CAN/AML arm vs. CAN/AML arm
For the percentage change in LDL-C levels at baseline and after 3 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage change in baseline-adjusted LDL-C levels from baseline after 3 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with percentage change in LDL-C levels as response variable and baseline LDL-C level and treatment arm as independent variables.Percentage changes in TC, TG, HDL-C, apolipoprotein B, and CRP levels from baseline after 3 and 6 weeks of study treatment week 3 and week 6 Co-Endpoints
For the TC, TG, HDL-C, apolipoprotein B, and CRP levels at baseline and after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage changes in baseline-adjusted TC, TG, HDL-C, apolipoprotein B, and CRP levels from baseline after 3 and 6 weeks of study treatment and their standard error will be provided by treatment arm. Inter-arm comparisons of the percentage changes at Week 3 and Week 6 will be conducted using the ANCOVA with each percentage change in TC, TG, HDL-C, apolipoprotein B, and CRP levels as response variable and relevant baseline level and treatment arm as independent variables.Change in siSBP from baseline after 3 weeks of study treatment week 3 EZE/ROS + CAN/AML arm vs. EZE/ROS + CAN arm
For the siSBP at baseline and after 3 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siSBP from baseline after 3 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with change in siSBP as response variable and baseline siSBP and treatment arm as independent variables.Changes in siSBPs from baseline after 3 and 6 weeks of study treatment week 3 and week 6 EZE/ROS + CAN/AML arm vs. CAN/AML arm
For the siSBP at baseline and after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siSBP from baseline after 3 and 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with change in siSBP as response variable and baseline siSBP and treatment arm as independent variables.Percentage changes in LDL-C/HDL-C and TC/HDL-C from baseline after 3 and 6 weeks of study treatment week 3 and week 6 EZE/ROS + CAN/AML arm vs. CAN/AML arm
For the LDL-C/HDL-C and TC/HDL-C at baseline and for their percentage changes after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum were presented by treatment arm. The LS-mean percentage changes in baseline-adjusted LDL-C/HDL-C and TC/HDL-C levels from baseline after 3 and 6 weeks of study treatment and their standard errors will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with percentage changes in LDL-C/HDL-C and TC/HDL-C levels as response variables and baseline LDL-C/HDL-C and TC/HDL-C levels and treatment arm as independent variables.Changes in siDBPs from baseline after 3 and 6 weeks of study treatment week 3 and week 6 Co-Endpoints
For the siDBP at baseline and after 3 and 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siDBP from baseline after 3 and 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with change in siDBP as response variable and baseline siDBP and treatment arm as independent variables.Proportions of subjects who achieve the treatment goal based on JNC VIII Guideline from baseline after 3 and 6 weeks of study treatment week 3 and week 6 Co-Endpoints
(HTN treatment goal: \<140/90 mmHg \[or \<150/90 mmHg for patients aged ≥60 years\]) The frequencies and proportions of subjects who achieve the treatment goal based on JNC VIII Guideline from baseline after 3 and 6 weeks of study treatment will be provided by treatment arm. The differences in the proportions of subjects who achieve the treatment goal after 3 and 6 weeks of study treatment between treatment arms will be analyzed using the Pearson's chi-square test or the Fisher's exact test.
Trial Locations
- Locations (1)
Bundang Seoul National University Hospital
🇰🇷Gyeonggi-do, Seongnam-si, Bundang-gu, Korea, Republic of