to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia
The purpose of this phase III study was to evaluate the efficacy and safety of CKD-348(CKD-828, D326, D337) tablet administration for treatment period(8 weeks) in essential hypertesive patients with Dyslipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
orally, 1 tablet once a day for 8 weeks
orally, 1 tablet once a day for 8 weeks
orally, 1 tablet once a day for 8 weeks
Korea University Guro Hospital
Seoul, South Korea
RECRUITINGChange rate from baseline in Low Density Lipoprotein-C
(compare treatment group with comparator group 1)
Time frame: Baseline, 8 weeks
Change from baseline in Mean Sitting Systolic Blood Pressure
(compare treatment group with comparator group 2)
Time frame: Baseline, 8 weeks
Change rate from baseline in Low Density Lipoprotein-C
Time frame: Baseline, 4 weeks
Change from baseline in Low Density Lipoprotein-C
Time frame: Baseline, 4 weeks, 8 weeks
Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C
Time frame: Baseline, 4 weeks, 8 weeks
Low Density Lipoprotein-C target achievement rate accroding to National Cholesterol Education Program(NCEP) Third Adult Treatment Panel(ATP III) guideline at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Change from baseline in Mean Sitting Systolic Blood Pressure
Time frame: Baseline, 4 weeks
Change from baseline in Mean Sitting Diastolic Blood Pressure
Time frame: Baseline, 4 weeks, 8 weeks
Normalization rate of blood pressure after 4 weeks and 8 weeks
Blood Pressure \< 140/90 mmHg
Time frame: Baseline, 4 weeks, 8 weeks
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orally, 1 tablet once a day for 8 weeks
orally, 1 tablet once a day for 8 weeks
orally, 1 tablet once a day for 8 weeks
orally, 1 tablet once a day for 8 weeks
orally, 1 tablet once a day for 8 weeks