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

Phase 3

Completed

• Conditions: Hypertensive Patients With Dyslipidemia
• Interventions: Drug: CKD-330; Drug: Placebo of CKD-330; Drug: Placebo of D086; Drug: D086; Drug: Placebo of D723; Drug: D723

• Registration Number: NCT03583905
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

To Evaluate the Efficacy and Safety of CKD-333

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 Timeline

• Status Verified: 2018-04
• Study Start: 2018-04-04
• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-12
• Primary Completion: 2019-07-17
• Study Completion: 2019-07-17
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group 1	Placebo of D723	Patients assigned to this group are treated with CKD-330, D086
Experimental Group 1	CKD-330	Patients assigned to this group are treated with CKD-330, D086
Placebo Group 1	Placebo of D086	Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)
Placebo Group 1	CKD-330	Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)
Placebo Group 1	Placebo of D723	Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)
Placebo Group 2	Placebo of CKD-330	Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)
Placebo Group 2	D086	Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)
Placebo Group 2	D723	Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)
Experimental Group 1	D086	Patients assigned to this group are treated with CKD-330, D086

Primary Outcome Measures

Name	Time	Method
Change rate from baseline in LDL-C	8 weeks after drug administrations	Compare experimental group 1 with placebo group 1
Change from baseline in MSSBP	8 weeks after drug administrations	Compare experimental group 1 with placebo group 2

Secondary Outcome Measures

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

Trial Locations

Locations (16)

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Catholic University Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

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

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

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

Korea University Anam 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; 🇰🇷 Seoul, Korea, Republic of

Seoul Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul Medical Center; 🇰🇷 Seoul, Korea, Republic of