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Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet

Primary Purpose

Hypertensive Patients With Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-330
Placebo of CKD-330
D086
Placebo of D086
D723
Placebo of D723
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Patients With Dyslipidemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period

  2. Lipid levels measured after run-in period were:

    • Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL
    • Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL
    • Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL

Exclusion Criteria:

  1. Patients whose blood pressures measured at Visit 2 were:

    • Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg

  2. Patients who had lipid levels measured at Visit 2

    • Patients with fasting LDL-C <100 mg / dL or fasting LDL-C> 250 mg / dL and / or TG ≥ 500 mg / dL

Sites / Locations

  • Dong-A University Hospital
  • Pusan National University Hospital
  • Chonnam National University Hospital
  • Gachon University Gil Hospital
  • Catholic University Seoul St. Mary's Hospital
  • Hanyang University Hospital
  • Kangbuk Samsung Hospital
  • Korea University Anam Hospital
  • Korea University Guro Hospital
  • Kyunghee University Hospital
  • Samsung Medical Center
  • Seoul Asan Medical Center
  • Seoul Medical Center
  • Yonsei University Medical Center Gangnam Severance Hospital
  • Yonsei University Medical Center Severance Hospital
  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Experimental Group 1

Placebo Group 1

Placebo Group 2

Arm Description

Patients assigned to this group are treated with CKD-330, D086

Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)

Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)

Outcomes

Primary Outcome Measures

Change rate from baseline in LDL-C
Compare experimental group 1 with placebo group 1
Change from baseline in MSSBP
Compare experimental group 1 with placebo group 2

Secondary Outcome Measures

Change rate from baseline in LDL-C
Compare experimental group 1 with placebo group 1
Change from baseline in LDL-C
Compare experimental group 1 with placebo group 1
Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline
Compare experimental group 1 with placebo group 1
Change from baseline in MSSBP(mmHg)
Compare experimental group 1 with placebo group 2
Change from baseline in MSDBP
Compare experimental group 1 with placebo group 2
Attainment of normal blood pressure as defined by JNC Ⅶ
Compare experimental group 1 with placebo group 2
Change from baseline in TC
Compare experimental group 1 with placebo group 1
Change from baseline in TG
Compare experimental group 1 with placebo group 1
Change from baseline in HDL-C
Compare experimental group 1 with placebo group 1
change rate from baseline in TC
Compare experimental group 1 with placebo group 1
change rate from baseline in TG
Compare experimental group 1 with placebo group 1
change rate from baseline in HDL-C
Compare experimental group 1 with placebo group 1

Full Information

First Posted
May 24, 2018
Last Updated
July 22, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03583905
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet
Official Title
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients With Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)

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

5. Study Description

Brief Summary
To Evaluate the Efficacy and Safety of CKD-333
Detailed Description
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Patients With Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
Patients assigned to this group are treated with CKD-330, D086
Arm Title
Placebo Group 1
Arm Type
Placebo Comparator
Arm Description
Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)
Arm Title
Placebo Group 2
Arm Type
Placebo Comparator
Arm Description
Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)
Intervention Type
Drug
Intervention Name(s)
CKD-330
Intervention Description
CKD-330 Tab.
Intervention Type
Drug
Intervention Name(s)
Placebo of CKD-330
Intervention Description
Placebo of CKD-330 Tab.
Intervention Type
Drug
Intervention Name(s)
D086
Intervention Description
D086 Tab.
Intervention Type
Drug
Intervention Name(s)
Placebo of D086
Intervention Description
Placebo of D086 Tab.
Intervention Type
Drug
Intervention Name(s)
D723
Intervention Description
D723 Tab.
Intervention Type
Drug
Intervention Name(s)
Placebo of D723
Intervention Description
Placebo of D723 Tab.
Primary Outcome Measure Information:
Title
Change rate from baseline in LDL-C
Description
Compare experimental group 1 with placebo group 1
Time Frame
8 weeks after drug administrations
Title
Change from baseline in MSSBP
Description
Compare experimental group 1 with placebo group 2
Time Frame
8 weeks after drug administrations
Secondary Outcome Measure Information:
Title
Change rate from baseline in LDL-C
Description
Compare experimental group 1 with placebo group 1
Time Frame
4 weeks after drug administrations
Title
Change from baseline in LDL-C
Description
Compare experimental group 1 with placebo group 1
Time Frame
4, 8 weeks after drug administrations
Title
Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline
Description
Compare experimental group 1 with placebo group 1
Time Frame
4, 8 weeks after drug administrations
Title
Change from baseline in MSSBP(mmHg)
Description
Compare experimental group 1 with placebo group 2
Time Frame
4 weeks after drug administrations
Title
Change from baseline in MSDBP
Description
Compare experimental group 1 with placebo group 2
Time Frame
4, 8 weeks after drug administrations
Title
Attainment of normal blood pressure as defined by JNC Ⅶ
Description
Compare experimental group 1 with placebo group 2
Time Frame
4, 8 weeks after drug administrations
Title
Change from baseline in TC
Description
Compare experimental group 1 with placebo group 1
Time Frame
4, 8 weeks after drug administrations
Title
Change from baseline in TG
Description
Compare experimental group 1 with placebo group 1
Time Frame
4, 8 weeks after drug administrations
Title
Change from baseline in HDL-C
Description
Compare experimental group 1 with placebo group 1
Time Frame
4, 8 weeks after drug administrations
Title
change rate from baseline in TC
Description
Compare experimental group 1 with placebo group 1
Time Frame
4, 8 weeks after drug administrations
Title
change rate from baseline in TG
Description
Compare experimental group 1 with placebo group 1
Time Frame
4, 8 weeks after drug administrations
Title
change rate from baseline in HDL-C
Description
Compare experimental group 1 with placebo group 1
Time Frame
4, 8 weeks after drug administrations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period Lipid levels measured after run-in period were: Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL Exclusion Criteria: Patients whose blood pressures measured at Visit 2 were: Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg Patients who had lipid levels measured at Visit 2 Patients with fasting LDL-C <100 mg / dL or fasting LDL-C> 250 mg / dL and / or TG ≥ 500 mg / dL
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Catholic University Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Medical Center Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Medical Center Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet

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