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Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

Primary Purpose

Dyslipidemia Patients With Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
D013, D326, D337
placebo of D013, D326, D337
D013, placebo of D326, placebo of D337
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia Patients With Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis.
  2. Subjects who agreed to participate in this clinical trial voluntarily.

Exclusion Criteria:

  1. Subjects who were satisfied specific blood pressure levels that measured at screening period.
  2. Subjects who were satisfied specific lipid levels that measured at screening period.
  3. Subjects who cannot participate in a clinical trial based on the PI's judgment.

Sites / Locations

  • Yonsei University Medical Center Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Experimental Group 1

Comparator Group 1

Comparator Group 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 12, 2020
Last Updated
July 26, 2021
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04312698
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386
Official Title
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of D013, D326 and D337 Combination Therapy in Dyslipidemia Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 29, 2019 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Title
Comparator Group 1
Arm Type
Placebo Comparator
Arm Title
Comparator Group 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
D013, D326, D337
Other Intervention Name(s)
Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Intervention Description
Experimental: Group 1 Patients assigned to this group are treated with D013, D326, D337
Intervention Type
Drug
Intervention Name(s)
placebo of D013, D326, D337
Other Intervention Name(s)
Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Intervention Description
Placebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013
Intervention Type
Drug
Intervention Name(s)
D013, placebo of D326, placebo of D337
Other Intervention Name(s)
Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Intervention Description
Placebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337
Primary Outcome Measure Information:
Title
Change rate from baseline in LDL-C
Description
Compare experimental group 1 with comparator group 1
Time Frame
8 weeks after drug administrations
Title
Change from baseline in MSSBP
Description
Compare experimental group 1 with comparator group 2
Time Frame
8 weeks after drug administrations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis. Subjects who agreed to participate in this clinical trial voluntarily. Exclusion Criteria: Subjects who were satisfied specific blood pressure levels that measured at screening period. Subjects who were satisfied specific lipid levels that measured at screening period. Subjects who cannot participate in a clinical trial based on the PI's judgment.
Facility Information:
Facility Name
Yonsei University Medical Center Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

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