Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet
NCT ID: NCT04388215
Last Updated: 2020-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2019-10-23
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group
Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg
\- CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
CKD-828
orally, 1 tablet once a day for 8 weeks
D326
orally, 1 tablet once a day for 8 weeks
D337
orally, 1 tablet once a day for 8 weeks
D013(placebo)
orally, 1 tablet once a day for 8 weeks
Comparator group 1
Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg
\- CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks
CKD-828
orally, 1 tablet once a day for 8 weeks
D326(placebo)
orally, 1 tablet once a day for 8 weeks
D337(placebo)
orally, 1 tablet once a day for 8 weeks
D013(placebo)
orally, 1 tablet once a day for 8 weeks
Comparator group 2
Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg
\- CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks
CKD-828(placebo)
orally, 1 tablet once a day for 8 weeks
D326
orally, 1 tablet once a day for 8 weeks
D337
orally, 1 tablet once a day for 8 weeks
D013
orally, 1 tablet once a day for 8 weeks
Interventions
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CKD-828
orally, 1 tablet once a day for 8 weeks
CKD-828(placebo)
orally, 1 tablet once a day for 8 weeks
D326
orally, 1 tablet once a day for 8 weeks
D326(placebo)
orally, 1 tablet once a day for 8 weeks
D337
orally, 1 tablet once a day for 8 weeks
D337(placebo)
orally, 1 tablet once a day for 8 weeks
D013
orally, 1 tablet once a day for 8 weeks
D013(placebo)
orally, 1 tablet once a day for 8 weeks
Eligibility Criteria
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Inclusion Criteria
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
* 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).
19 Years
75 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Chang Gyu Park, M.D, Ph.D.
Role: primary
Other Identifiers
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A86_03HT/DL1905
Identifier Type: -
Identifier Source: org_study_id
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