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Completed

NCT Number: NCT04312698

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

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

Completed

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Key information

Conditions

Dyslipidemia Patients With Hypertension

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University Medical Center Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D013, D326, D337

Drug

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 of D013, D326, D337

Drug

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

D013, placebo of D326, placebo of D337

Drug

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

Primary outcomes

  1. Change rate from baseline in LDL-C

    Time frame: 8 weeks after drug administrations

    Compare experimental group 1 with comparator group 1

  2. Change from baseline in MSSBP

    Time frame: 8 weeks after drug administrations

    Compare experimental group 1 with comparator group 2

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.