Status:
UNKNOWN
Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension
Dyslipidemias
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
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 D...
Eligibility Criteria
Inclusion
- Between 19 years and 75 years old(male or female)
- Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs
- The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion
- Agreement with written informed consent
Exclusion
- 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
- Patients whose lipid level measured at screening is one of the following:
- Low Density Lipoprotein-C \> 250 mg/dL or Triglyceride ≥ 500 mg/dL
- Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04388215
Start Date
October 23 2019
End Date
April 1 2021
Last Update
May 14 2020
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea