Hypertensive Patients With Dyslipidemia Clinical Trial
Official title:
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
| Verified date | April 2018 |
| Source | Chong Kun Dang Pharmaceutical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To Evaluate the Efficacy and Safety of CKD-333
| Status | Completed |
| Enrollment | 154 |
| Est. completion date | July 17, 2019 |
| Est. primary completion date | July 17, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Gachon University Gil Hospital | Incheon | |
| Korea, Republic of | Catholic University Seoul St. Mary's Hospital | Seoul | |
| Korea, Republic of | Hanyang University Hospital | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Kyunghee University Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul Asan Medical Center | Seoul | |
| Korea, Republic of | Seoul Medical Center | Seoul | |
| Korea, Republic of | Yonsei University Medical Center Gangnam Severance Hospital | Seoul | |
| Korea, Republic of | Yonsei University Medical Center Severance Hospital | Seoul | |
| Korea, Republic of | Wonju Severance Christian Hospital | Wonju |
| Lead Sponsor | Collaborator |
|---|---|
| Chong Kun Dang Pharmaceutical |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change rate from baseline in LDL-C | Compare experimental group 1 with placebo group 1 | 8 weeks after drug administrations | |
| Primary | Change from baseline in MSSBP | Compare experimental group 1 with placebo group 2 | 8 weeks after drug administrations | |
| Secondary | Change rate from baseline in LDL-C | Compare experimental group 1 with placebo group 1 | 4 weeks after drug administrations | |
| Secondary | Change from baseline in LDL-C | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | |
| Secondary | Attainment of LDL-C treatment goal as defined by NCEP ATP ? Guideline | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | |
| Secondary | Change from baseline in MSSBP(mmHg) | Compare experimental group 1 with placebo group 2 | 4 weeks after drug administrations | |
| Secondary | Change from baseline in MSDBP | Compare experimental group 1 with placebo group 2 | 4, 8 weeks after drug administrations | |
| Secondary | Attainment of normal blood pressure as defined by JNC ? | Compare experimental group 1 with placebo group 2 | 4, 8 weeks after drug administrations | |
| Secondary | Change from baseline in TC | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | |
| Secondary | Change from baseline in TG | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | |
| Secondary | Change from baseline in HDL-C | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | |
| Secondary | change rate from baseline in TC | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | |
| Secondary | change rate from baseline in TG | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | |
| Secondary | change rate from baseline in HDL-C | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |