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

July 26, 2021 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Yonsei University Medical Center Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group 1
Drug: D013, D326, D337
Experimental: Group 1 Patients assigned to this group are treated with D013, D326, D337
Other Names:
  • Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Placebo Comparator: Comparator Group 1
Drug: placebo of D013, D326, D337
Placebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013
Other Names:
  • Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Placebo Comparator: Comparator Group 2
Drug: D013, placebo of D326, placebo of D337
Placebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337
Other Names:
  • Drugs are consist of antihypertensive agent and antihyperlipidemic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change rate from baseline in LDL-C
Time Frame: 8 weeks after drug administrations
Compare experimental group 1 with comparator group 1
8 weeks after drug administrations
Change from baseline in MSSBP
Time Frame: 8 weeks after drug administrations
Compare experimental group 1 with comparator group 2
8 weeks after drug administrations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2019

Primary Completion (Actual)

June 18, 2021

Study Completion (Actual)

June 18, 2021

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A83_03DL/HT1903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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