Clinical trial NCT03583905: Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertensive Patients With Dyslipidemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-07-12
Enrollment: 154
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change rate from baseline in LDL-C
timeFrame: 8 weeks after drug administrations
measure: Change from baseline in MSSBP
timeFrame: 8 weeks after drug administrations
Secondary outcomes:
measure: Change rate from baseline in LDL-C
timeFrame: 4 weeks after drug administrations
measure: Change from baseline in LDL-C
timeFrame: 4, 8 weeks after drug administrations
measure: Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline
timeFrame: 4, 8 weeks after drug administrations
measure: Change from baseline in MSSBP(mmHg)
timeFrame: 4 weeks after drug administrations
measure: Change from baseline in MSDBP
timeFrame: 4, 8 weeks after drug administrations
measure: Attainment of normal blood pressure as defined by JNC Ⅶ
timeFrame: 4, 8 weeks after drug administrations
measure: Change from baseline in TC
timeFrame: 4, 8 weeks after drug administrations
measure: Change from baseline in TG
timeFrame: 4, 8 weeks after drug administrations
measure: Change from baseline in HDL-C
timeFrame: 4, 8 weeks after drug administrations
measure: change rate from baseline in TC
timeFrame: 4, 8 weeks after drug administrations
measure: change rate from baseline in TG
timeFrame: 4, 8 weeks after drug administrations
measure: change rate from baseline in HDL-C
timeFrame: 4, 8 weeks after drug administrations
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Medical Center Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Medical Center Severance Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
References: