Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients With Dyslipidemia

To Evaluate the Efficacy and Safety of CKD-333

Study Overview

• Status: Completed
• Conditions: Hypertensive Patients With Dyslipidemia
• Intervention / Treatment: Drug: CKD-330; Drug: D086; Drug: Placebo of D723; Drug: Placebo of D086; Drug: Placebo of CKD-330; Drug: D723

Detailed Description

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Seoul Medical Center
  • Seoul, Korea, Republic of
    • Seoul Asan Medical Center
  • Seoul, Korea, Republic of
    • Catholic University Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of
    • KyungHee University Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Medical Center Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Medical Center Severance Hospital
  • Wonju, Korea, Republic of
    • WonJu Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period

2. Lipid levels measured after run-in period were:

   • Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL
   • Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL
   • Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL

Exclusion Criteria:

1. Patients whose blood pressures measured at Visit 2 were:

   • Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg

2. Patients who had lipid levels measured at Visit 2

   • Patients with fasting LDL-C <100 mg / dL or fasting LDL-C> 250 mg / dL and / or TG ≥ 500 mg / dL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group 1; Patients assigned to this group are treated with CKD-330, D086	Drug: CKD-330; CKD-330 Tab.; Drug: D086; D086 Tab.; Drug: Placebo of D723; Placebo of D723 Tab.
Placebo Comparator: Placebo Group 1; Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)	Drug: CKD-330; CKD-330 Tab.; Drug: Placebo of D723; Placebo of D723 Tab.; Drug: Placebo of D086; Placebo of D086 Tab.
Placebo Comparator: Placebo Group 2; Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)	Drug: D086; D086 Tab.; Drug: Placebo of CKD-330; Placebo of CKD-330 Tab.; Drug: D723; D723 Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change rate from baseline in LDL-C	Compare experimental group 1 with placebo group 1	8 weeks after drug administrations
Change from baseline in MSSBP	Compare experimental group 1 with placebo group 2	8 weeks after drug administrations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change rate from baseline in LDL-C	Compare experimental group 1 with placebo group 1	4 weeks after drug administrations
Change from baseline in LDL-C	Compare experimental group 1 with placebo group 1	4, 8 weeks after drug administrations
Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline	Compare experimental group 1 with placebo group 1	4, 8 weeks after drug administrations
Change from baseline in MSSBP(mmHg)	Compare experimental group 1 with placebo group 2	4 weeks after drug administrations
Change from baseline in MSDBP	Compare experimental group 1 with placebo group 2	4, 8 weeks after drug administrations
Attainment of normal blood pressure as defined by JNC Ⅶ	Compare experimental group 1 with placebo group 2	4, 8 weeks after drug administrations
Change from baseline in TC	Compare experimental group 1 with placebo group 1	4, 8 weeks after drug administrations
Change from baseline in TG	Compare experimental group 1 with placebo group 1	4, 8 weeks after drug administrations
Change from baseline in HDL-C	Compare experimental group 1 with placebo group 1	4, 8 weeks after drug administrations
change rate from baseline in TC	Compare experimental group 1 with placebo group 1	4, 8 weeks after drug administrations
change rate from baseline in TG	Compare experimental group 1 with placebo group 1	4, 8 weeks after drug administrations
change rate from baseline in HDL-C	Compare experimental group 1 with placebo group 1	4, 8 weeks after drug administrations

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 170HT/DL17007

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