Dyslipidemias, Hypertension
Conditions
Brief summary
to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia
Detailed description
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.
Interventions
DRUGCKD-828
orally, 1 tablet once a day for 8 weeks
DRUGCKD-828(placebo)
orally, 1 tablet once a day for 8 weeks
DRUGD326
orally, 1 tablet once a day for 8 weeks
DRUGD326(placebo)
orally, 1 tablet once a day for 8 weeks
DRUGD337
orally, 1 tablet once a day for 8 weeks
DRUGD337(placebo)
orally, 1 tablet once a day for 8 weeks
DRUGD013
orally, 1 tablet once a day for 8 weeks
DRUGD013(placebo)
orally, 1 tablet once a day for 8 weeks
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Between 19 years and 75 years old(male or female) 2. Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs 3. The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion 4. Agreement with written informed consent
Exclusion criteria
1. Patients whose blood pressure measured at screening is one of the following: * Mean Sitting Systolic Blood Pressure ≥ 200 mmHg or Mean Sitting Diastolic Blood Pressure ≥ 120 mmHg * Difference in Mean Sitting Systolic Blood Pressure between patient's both arms ≥ 20 mmHg and Mean Sitting Diastolic Blood Pressure ≥ 10 mmHg 2. Patients whose lipid level measured at screening is one of the following: * Low Density Lipoprotein-C \> 250 mg/dL or Triglyceride ≥ 500 mg/dL 3. Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change rate from baseline in Low Density Lipoprotein-C | Baseline, 8 weeks | (compare treatment group with comparator group 1) |
| Change from baseline in Mean Sitting Systolic Blood Pressure | Baseline, 8 weeks | (compare treatment group with comparator group 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change rate from baseline in Low Density Lipoprotein-C | Baseline, 4 weeks | — |
| Change from baseline in Low Density Lipoprotein-C | Baseline, 4 weeks, 8 weeks | — |
| Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C | 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 | Baseline, 4 weeks, 8 weeks | — |
| Change from baseline in Mean Sitting Systolic Blood Pressure | Baseline, 4 weeks | — |
| Change from baseline in Mean Sitting Diastolic Blood Pressure | Baseline, 4 weeks, 8 weeks | — |
| Normalization rate of blood pressure after 4 weeks and 8 weeks | Baseline, 4 weeks, 8 weeks | Blood Pressure \< 140/90 mmHg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Normalization rate of blood pressure after 4 weeks and 8 weeks | Baseline, 4 weeks, 8 weeks | Blood Pressure \< 140/90 mmHg |
| Change from baseline in Mean Sitting Systolic Blood Pressure and Mean Mean Sitting Diastolic Blood Pressure | 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 | Baseline, 4 weeks, 8 weeks | — |
| Change and change rate from baseline in Low Density Lipoprotein-C, Total Cholesterol, Triglyceride, High Density Lipoprotein-C | Baseline, 4 weeks, 8 weeks | — |
Countries
South Korea
Contacts
Primary ContactChangGyu Park, M.D, Ph.D
Outcome results
None listed