Completed

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

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What is being tested

D013, D326, D337

+ placebo of D013, D326, D337

+ D013, placebo of D326, placebo of D337

Drug
Who is being recruted

Over 19 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: August 2019
See protocol details

Summary

Principal SponsorChong Kun Dang Pharmaceutical
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 29, 2019

Actual date on which the first participant was enrolled.

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

Official TitleA 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
NCT04312698
Principal SponsorChong Kun Dang Pharmaceutical
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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.
3 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

66.667% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Group III

Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Yonsei University Medical Center Severance Hospital

Seoul, South KoreaOpen Yonsei University Medical Center Severance Hospital in Google Maps
CompletedOne Study Center