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

Phase 3

• Conditions: Hypertension; Dyslipidemias
• Interventions: Drug: CKD-828; Drug: CKD-828(placebo); Drug: D326; Drug: D326(placebo); Drug: D337; Drug: D337(placebo); Drug: D013(placebo); Drug: D013

• Registration Number: NCT04388215
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-10-23
• Status Verified: 2020-05
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-14
• Last Update Posted: 2020-05-14
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	CKD-828	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 group	D326	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 group	D337	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 group	D013(placebo)	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
Comparator group 1	CKD-828	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
Comparator group 1	D326(placebo)	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
Comparator group 1	D337(placebo)	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
Comparator group 1	D013(placebo)	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
Comparator group 2	CKD-828(placebo)	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
Comparator group 2	D326	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
Comparator group 2	D337	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
Comparator group 2	D013	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

Primary Outcome Measures

Name	Time	Method
Change rate from baseline in Low Density Lipoprotein-C	Baseline, 8 weeks	(compare treatment group with comparator group 1)
Change from baseline in Mean Sitting Systolic Blood Pressure	Baseline, 8 weeks	(compare treatment group with comparator group 2)

Secondary Outcome Measures

Name	Time	Method
Change rate from baseline in Low Density Lipoprotein-C	Baseline, 4 weeks
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	Baseline, 4 weeks, 8 weeks
Change from baseline in Low Density Lipoprotein-C	Baseline, 4 weeks, 8 weeks
Change from baseline in Mean Sitting Systolic Blood Pressure	Baseline, 4 weeks
Change from baseline in Mean Sitting Diastolic Blood Pressure	Baseline, 4 weeks, 8 weeks
Normalization rate of blood pressure after 4 weeks and 8 weeks	Baseline, 4 weeks, 8 weeks	Blood Pressure \< 140/90 mmHg
Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C	Baseline, 4 weeks, 8 weeks

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of