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

NCT04388215 | Unknown Phase 3

• 1 other identifier: A86_03HT/DL1905
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Other Outcomes (4)

• Change and change rate from baseline in Low Density Lipoprotein-C, 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 and Mean Mean Sitting Diastolic Blood Pressure

  Baseline, 4 weeks, 8 weeks

Study Arms (3)

Treatment group

EXPERIMENTAL

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; Drug: D326; Drug: D337; Drug: D013(placebo)

Comparator group 1

ACTIVE COMPARATOR

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; Drug: D326(placebo); Drug: D337(placebo); Drug: D013(placebo)

Comparator group 2

ACTIVE COMPARATOR

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

Interventions

CKD-828 DRUG

orally, 1 tablet once a day for 8 weeks

Comparator group 1; Treatment group

CKD-828(placebo) DRUG

orally, 1 tablet once a day for 8 weeks

Comparator group 2

D326 DRUG

orally, 1 tablet once a day for 8 weeks

Comparator group 2; Treatment group

D326(placebo) DRUG

orally, 1 tablet once a day for 8 weeks

Comparator group 1

D337 DRUG

orally, 1 tablet once a day for 8 weeks

Comparator group 2; Treatment group

D337(placebo) DRUG

orally, 1 tablet once a day for 8 weeks

Comparator group 1

D013 DRUG

orally, 1 tablet once a day for 8 weeks

Comparator group 2

D013(placebo) DRUG

orally, 1 tablet once a day for 8 weeks

Comparator group 1; Treatment group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 19 years and 75 years old(male or female)
• Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs
• The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion
• Agreement with written informed consent

You may not qualify if:

• 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
• Patients whose lipid level measured at screening is one of the following:
• Low Density Lipoprotein-C \> 250 mg/dL or Triglyceride ≥ 500 mg/dL
• Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

ChangGyu Park, M.D, Ph.D

CONTACT

+82-2-2626-3019; parkch@kumc.or.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: October 23, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)