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

Chong Kun Dang

Status and phase: Unknown; Phase 3

Conditions: Hypertension; Dyslipidemias

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

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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: D013(placebo)

Drug: D326

Drug: CKD-828

Drug: D337

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: CKD-828

Drug: D337(placebo)

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: D013

Drug: D326

Drug: CKD-828(placebo)

Drug: D337