Clinical trial NCT04388215: Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-828, D326, and D337 Combination Therapy in Hypertensive Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-05-14
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
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-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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change rate from baseline in Low Density Lipoprotein-C
timeFrame: Baseline, 8 weeks
measure: Change from baseline in Mean Sitting Systolic Blood Pressure
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change rate from baseline in Low Density Lipoprotein-C
timeFrame: Baseline, 4 weeks
measure: Change from baseline in Low Density Lipoprotein-C
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C
timeFrame: Baseline, 4 weeks, 8 weeks
measure: 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
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from baseline in Mean Sitting Systolic Blood Pressure
timeFrame: Baseline, 4 weeks
measure: Change from baseline in Mean Sitting Diastolic Blood Pressure
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Normalization rate of blood pressure after 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
measure: Change and change rate from baseline in Low Density Lipoprotein-C, Total Cholesterol, Triglyceride, High Density Lipoprotein-C
timeFrame: Baseline, 4 weeks, 8 weeks
measure: 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
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from baseline in Mean Sitting Systolic Blood Pressure and Mean Mean Sitting Diastolic Blood Pressure
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Normalization rate of blood pressure after 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, 8 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References: