Back to resultsClinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet
Primary Purpose
Hypertension, Dyslipidemias
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-828
CKD-828(placebo)
D326
D326(placebo)
D337
D337(placebo)
D013
D013(placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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).
Sites / Locations
- Korea University Guro HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Treatment group
Comparator group 1
Comparator group 2
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
Change rate from baseline in Low Density Lipoprotein-C
(compare treatment group with comparator group 1)
Change from baseline in Mean Sitting Systolic Blood Pressure
(compare treatment group with comparator group 2)
Secondary Outcome Measures
Change rate from baseline in Low Density Lipoprotein-C
Change from baseline in Low Density Lipoprotein-C
Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C
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
Change from baseline in Mean Sitting Systolic Blood Pressure
Change from baseline in Mean Sitting Diastolic Blood Pressure
Normalization rate of blood pressure after 4 weeks and 8 weeks
Blood Pressure < 140/90 mmHg
Full Information
NCT ID
NCT04388215
First Posted
May 11, 2020
Last Updated
May 11, 2020
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT04388215
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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
Arm Title
Comparator group 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Comparator group 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CKD-828
Intervention Description
orally, 1 tablet once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
CKD-828(placebo)
Intervention Description
orally, 1 tablet once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
D326
Intervention Description
orally, 1 tablet once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
D326(placebo)
Intervention Description
orally, 1 tablet once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
D337
Intervention Description
orally, 1 tablet once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
D337(placebo)
Intervention Description
orally, 1 tablet once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
D013
Intervention Description
orally, 1 tablet once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
D013(placebo)
Intervention Description
orally, 1 tablet once a day for 8 weeks
Primary Outcome Measure Information:
Title
Change rate from baseline in Low Density Lipoprotein-C
Description
(compare treatment group with comparator group 1)
Time Frame
Baseline, 8 weeks
Title
Change from baseline in Mean Sitting Systolic Blood Pressure
Description
(compare treatment group with comparator group 2)
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change rate from baseline in Low Density Lipoprotein-C
Time Frame
Baseline, 4 weeks
Title
Change from baseline in Low Density Lipoprotein-C
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C
Time Frame
Baseline, 4 weeks, 8 weeks
Title
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
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from baseline in Mean Sitting Systolic Blood Pressure
Time Frame
Baseline, 4 weeks
Title
Change from baseline in Mean Sitting Diastolic Blood Pressure
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Normalization rate of blood pressure after 4 weeks and 8 weeks
Description
Blood Pressure < 140/90 mmHg
Time Frame
Baseline, 4 weeks, 8 weeks
Other Pre-specified Outcome Measures:
Title
Change and change rate from baseline in Low Density Lipoprotein-C, Total Cholesterol, Triglyceride, High Density Lipoprotein-C
Time Frame
Baseline, 4 weeks, 8 weeks
Title
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
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from baseline in Mean Sitting Systolic Blood Pressure and Mean Mean Sitting Diastolic Blood Pressure
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Normalization rate of blood pressure after 4 weeks and 8 weeks
Description
Blood Pressure < 140/90 mmHg
Time Frame
Baseline, 4 weeks, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ChangGyu Park, M.D, Ph.D
Phone
+82-2-2626-3019
Email
parkch@kumc.or.kr
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Gyu Park, M.D, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet
We'll reach out to this number within 24 hrs