NCT04312698

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1.8 years

First QC Date

March 12, 2020

Last Update Submit

July 26, 2021

Conditions

Dyslipidemia Patients With Hypertension

Outcome Measures

Primary Outcomes (2)

  • Change rate from baseline in LDL-C

    Compare experimental group 1 with comparator group 1

    8 weeks after drug administrations

  • Change from baseline in MSSBP

    Compare experimental group 1 with comparator group 2

    8 weeks after drug administrations

Study Arms (3)

Experimental Group 1

EXPERIMENTAL
Drug: D013, D326, D337

Comparator Group 1

PLACEBO COMPARATOR
Drug: placebo of D013, D326, D337

Comparator Group 2

PLACEBO COMPARATOR
Drug: D013, placebo of D326, placebo of D337

Interventions

D013, D326, D337DRUG

Experimental: Group 1 Patients assigned to this group are treated with D013, D326, D337

Also known as: Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Experimental Group 1
placebo of D013, D326, D337DRUG

Placebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013

Also known as: Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Comparator Group 1
D013, placebo of D326, placebo of D337DRUG

Placebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337

Also known as: Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Comparator Group 2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Medical Center Severance Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 18, 2020

Study Start

August 29, 2019

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)