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

NCT ID: NCT04312698

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-29

Study Completion Date

2021-06-18

Brief Summary

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

Detailed Description

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Conditions

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Dyslipidemia Patients With Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental Group 1

Group Type EXPERIMENTAL

D013, D326, D337

Intervention Type DRUG

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

Comparator Group 1

Group Type PLACEBO_COMPARATOR

placebo of D013, D326, D337

Intervention Type DRUG

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

Comparator Group 2

Group Type PLACEBO_COMPARATOR

D013, placebo of D326, placebo of D337

Intervention Type DRUG

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

Interventions

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D013, D326, D337

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

Intervention Type DRUG

placebo of D013, D326, D337

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Drugs are consist of antihypertensive agent and antihyperlipidemic agent Drugs are consist of antihypertensive agent and antihyperlipidemic agent Drugs are consist of antihypertensive agent and antihyperlipidemic agent

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University Medical Center Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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A83_03DL/HT1903

Identifier Type: -

Identifier Source: org_study_id

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