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

C

Chong Kun Dang

Status and phase

Unknown
Phase 3

Conditions

Hypertension
Dyslipidemias

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04388215
A86_03HT/DL1905

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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

  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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 3 patient groups

Treatment group
Experimental group
Description:
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
Treatment:
Drug: D337
Drug: D326
Drug: D013(placebo)
Drug: CKD-828
Comparator group 1
Active Comparator group
Description:
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
Treatment:
Drug: D326(placebo)
Drug: D013(placebo)
Drug: D337(placebo)
Drug: CKD-828
Comparator group 2
Active Comparator group
Description:
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
Treatment:
Drug: D337
Drug: D326
Drug: D013
Drug: CKD-828(placebo)

Trial contacts and locations

1

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Central trial contact

ChangGyu Park, M.D, Ph.D

Data sourced from clinicaltrials.gov

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