Overview

Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

Status:
Recruiting
Trial end date:
2021-04-01
Target enrollment:
0
Participant gender:
All
Summary
to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chong Kun Dang Pharmaceutical
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).