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

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-828, D326, and D337 Combination Therapy in Hypertensive Patients With Dyslipidemia

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

Study Overview

• Status: Unknown
• Conditions: Hypertension; Dyslipidemias
• Intervention / Treatment: Drug: CKD-828; Drug: D326; Drug: D337; Drug: D013(placebo); Drug: D326(placebo); Drug: D337(placebo); Drug: CKD-828(placebo); Drug: D013

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ChangGyu Park, M.D, Ph.D; Phone Number: +82-2-2626-3019; Email: parkch@kumc.or.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Chang Gyu Park, M.D, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; orally, 1 tablet once a day for 8 weeks; Drug: D326; orally, 1 tablet once a day for 8 weeks; Drug: D337; orally, 1 tablet once a day for 8 weeks; Drug: D013(placebo); orally, 1 tablet once a day for 8 weeks
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; orally, 1 tablet once a day for 8 weeks; Drug: D013(placebo); orally, 1 tablet once a day for 8 weeks; Drug: D326(placebo); orally, 1 tablet once a day for 8 weeks; Drug: D337(placebo); orally, 1 tablet once a day for 8 weeks
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: D326; orally, 1 tablet once a day for 8 weeks; Drug: D337; orally, 1 tablet once a day for 8 weeks; Drug: CKD-828(placebo); orally, 1 tablet once a day for 8 weeks; Drug: D013; orally, 1 tablet once a day for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change rate from baseline in Low Density Lipoprotein-C		Baseline, 4 weeks
Change from baseline in Low Density Lipoprotein-C		Baseline, 4 weeks, 8 weeks
Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C		Baseline, 4 weeks, 8 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 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	Blood Pressure < 140/90 mmHg	Baseline, 4 weeks, 8 weeks

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2019
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (ACTUAL): May 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: A86_03HT/DL1905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No