Hypertensive Patients With Dyslipidemia
Conditions
Brief summary
To Evaluate the Efficacy and Safety of CKD-333
Detailed description
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia
Interventions
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period 2. Lipid levels measured after run-in period were: * Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL * Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL * Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL
Exclusion criteria
1. Patients whose blood pressures measured at Visit 2 were: * Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg 2. Patients who had lipid levels measured at Visit 2 * Patients with fasting LDL-C \<100 mg / dL or fasting LDL-C\> 250 mg / dL and / or TG ≥ 500 mg / dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change rate from baseline in LDL-C | 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| Change from baseline in MSSBP | 8 weeks after drug administrations | Compare experimental group 1 with placebo group 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| Change from baseline in MSSBP(mmHg) | 4 weeks after drug administrations | Compare experimental group 1 with placebo group 2 |
| Change from baseline in MSDBP | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 2 |
| Attainment of normal blood pressure as defined by JNC Ⅶ | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 2 |
| Change from baseline in TC | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| Change rate from baseline in LDL-C | 4 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| Change from baseline in HDL-C | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| change rate from baseline in TC | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| change rate from baseline in TG | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| change rate from baseline in HDL-C | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| Change from baseline in TG | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
| Change from baseline in LDL-C | 4, 8 weeks after drug administrations | Compare experimental group 1 with placebo group 1 |
Countries
South Korea
Outcome results
None listed