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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04388215
• Other study ID #: A86_03HT/DL1905
• Status: Recruiting
• Phase: Phase 3
• Start date: October 23, 2019
• Est. completion date: April 2021

Study information

• Verified date: May 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: ChangGyu Park, M.D, Ph.D
• Phone: +82-2-2626-3019
• Email: parkch[@]kumc.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• CKD-828
orally, 1 tablet once a day for 8 weeks
• CKD-828(placebo)
orally, 1 tablet once a day for 8 weeks
• D326
orally, 1 tablet once a day for 8 weeks
• D326(placebo)
orally, 1 tablet once a day for 8 weeks
• D337
orally, 1 tablet once a day for 8 weeks
• D337(placebo)
orally, 1 tablet once a day for 8 weeks
• D013
orally, 1 tablet once a day for 8 weeks
• D013(placebo)
orally, 1 tablet once a day for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change and change rate from baseline in Low Density Lipoprotein-C, Total Cholesterol, Triglyceride, High Density Lipoprotein-C		Baseline, 4 weeks, 8 weeks
Other	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
Other	Change from baseline in Mean Sitting Systolic Blood Pressure and Mean Mean Sitting Diastolic Blood Pressure		Baseline, 4 weeks, 8 weeks
Other	Normalization rate of blood pressure after 4 weeks and 8 weeks	Blood Pressure < 140/90 mmHg	Baseline, 4 weeks, 8 weeks
Primary	Change rate from baseline in Low Density Lipoprotein-C	(compare treatment group with comparator group 1)	Baseline, 8 weeks
Primary	Change from baseline in Mean Sitting Systolic Blood Pressure	(compare treatment group with comparator group 2)	Baseline, 8 weeks
Secondary	Change rate from baseline in Low Density Lipoprotein-C		Baseline, 4 weeks
Secondary	Change from baseline in Low Density Lipoprotein-C		Baseline, 4 weeks, 8 weeks
Secondary	Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C		Baseline, 4 weeks, 8 weeks
Secondary	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
Secondary	Change from baseline in Mean Sitting Systolic Blood Pressure		Baseline, 4 weeks
Secondary	Change from baseline in Mean Sitting Diastolic Blood Pressure		Baseline, 4 weeks, 8 weeks
Secondary	Normalization rate of blood pressure after 4 weeks and 8 weeks	Blood Pressure < 140/90 mmHg	Baseline, 4 weeks, 8 weeks