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Status unknownNCT04388215Updated May 14, 2020

Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

A Phase 3 interventional study of CKD-828 and CKD-828(placebo) in Hypertension and Dyslipidemias, sponsored by Chong Kun Dang Pharmaceutical. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-14.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2019, registered May 2020).
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study summary

to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia

Read the detailed description

The purpose of this phase III study was to evaluate the efficacy and safety of CKD-348(CKD-828, D326, D337) tablet administration for treatment period(8 weeks) in essential hypertesive patients with Dyslipidemia.

02

Conditions studied

  • Hypertension
  • Dyslipidemias

Browse trials for

03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's planned enrollment of 120 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Between 19 years and 75 years old(male or female)
  2. Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs
  3. The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion
  4. Agreement with written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Patients whose blood pressure measured at screening is one of the following:

    • Mean Sitting Systolic Blood Pressure ≥ 200 mmHg or Mean Sitting Diastolic Blood Pressure ≥ 120 mmHg
    • Difference in Mean Sitting Systolic Blood Pressure between patient's both arms ≥ 20 mmHg and Mean Sitting Diastolic Blood Pressure ≥ 10 mmHg

  2. Patients whose lipid level measured at screening is one of the following:

    • Low Density Lipoprotein-C > 250 mg/dL or Triglyceride ≥ 500 mg/dL
  3. Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Treatment group

    Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg - CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks

    Drug: CKD-828 · Drug: D326 · Drug: D337 · Drug: D013(placebo)

  • Active comparator
    Comparator group 1

    Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg - CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks

    Drug: CKD-828 · Drug: D326(placebo) · Drug: D337(placebo) · Drug: D013(placebo)

  • Active comparator
    Comparator group 2

    Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg - CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks

    Drug: CKD-828(placebo) · Drug: D326 · Drug: D337 · Drug: D013

Interventions

  • DrugCKD-828

    orally, 1 tablet once a day for 8 weeks

  • DrugCKD-828(placebo)

    orally, 1 tablet once a day for 8 weeks

  • DrugD326

    orally, 1 tablet once a day for 8 weeks

  • DrugD326(placebo)

    orally, 1 tablet once a day for 8 weeks

  • DrugD337

    orally, 1 tablet once a day for 8 weeks

  • DrugD337(placebo)

    orally, 1 tablet once a day for 8 weeks

  • DrugD013

    orally, 1 tablet once a day for 8 weeks

  • DrugD013(placebo)

    orally, 1 tablet once a day for 8 weeks

06

What researchers measure

Primary outcomes

  1. Change rate from baseline in Low Density Lipoprotein-C

    (compare treatment group with comparator group 1)

    Time frame: Baseline, 8 weeks

  2. Change from baseline in Mean Sitting Systolic Blood Pressure

    (compare treatment group with comparator group 2)

    Time frame: Baseline, 8 weeks

Secondary outcomes

  1. Change rate from baseline in Low Density Lipoprotein-C

    Time frame: Baseline, 4 weeks

  2. Change from baseline in Low Density Lipoprotein-C

    Time frame: Baseline, 4 weeks, 8 weeks

  3. Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C

    Time frame: Baseline, 4 weeks, 8 weeks

  4. Low Density Lipoprotein-C target achievement rate accroding to National Cholesterol Education Program(NCEP) Third Adult Treatment Panel(ATP III) guideline at 4 weeks and 8 weeks

    Time frame: Baseline, 4 weeks, 8 weeks

  5. Change from baseline in Mean Sitting Systolic Blood Pressure

    Time frame: Baseline, 4 weeks

  6. Change from baseline in Mean Sitting Diastolic Blood Pressure

    Time frame: Baseline, 4 weeks, 8 weeks

  7. Normalization rate of blood pressure after 4 weeks and 8 weeks

    Blood Pressure \< 140/90 mmHg

    Time frame: Baseline, 4 weeks, 8 weeks

Other outcomes

  1. Change and change rate from baseline in Low Density Lipoprotein-C, Total Cholesterol, Triglyceride, High Density Lipoprotein-C

    Time frame: Baseline, 4 weeks, 8 weeks

  2. Low Density Lipoprotein-C target achievement rate accroding to National Cholesterol Education Program(NCEP) Third Adult Treatment Panel(ATP III) guideline at 4 weeks and 8 weeks

    Time frame: Baseline, 4 weeks, 8 weeks

  3. Change from baseline in Mean Sitting Systolic Blood Pressure and Mean Mean Sitting Diastolic Blood Pressure

    Time frame: Baseline, 4 weeks, 8 weeks

  4. Normalization rate of blood pressure after 4 weeks and 8 weeks

    Blood Pressure \< 140/90 mmHg

    Time frame: Baseline, 4 weeks, 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
    • Chang Gyu Park, M.D, Ph.D. · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04388215
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
May 14, 2020
Start date
Oct 23, 2019
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
May 14, 2020

Study contacts

ChangGyu Park, M.D, Ph.D
Contact
parkch@kumc.or.kr
+82-2-2626-3019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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