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

NCT03583905 | Completed Phase 3

• 1 other identifier: 170HT/DL17007
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 16

Brief Summary

To Evaluate the Efficacy and Safety of CKD-333

Conditions

Hypertensive Patients With Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Change rate from baseline in LDL-C

  4 weeks after drug administrations

• Change from baseline in LDL-C

  4, 8 weeks after drug administrations

• Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline

  4, 8 weeks after drug administrations

• Change from baseline in MSSBP(mmHg)

  4 weeks after drug administrations

• Change from baseline in MSDBP

  4, 8 weeks after drug administrations

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

Patients assigned to this group are treated with CKD-330, D086

Drug: CKD-330; Drug: D086; Drug: Placebo of D723

Placebo Group 1

PLACEBO COMPARATOR

Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)

Drug: CKD-330; Drug: Placebo of D086; Drug: Placebo of D723

Placebo Group 2

PLACEBO COMPARATOR

Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)

Drug: Placebo of CKD-330; Drug: D086; Drug: D723

Interventions

CKD-330 DRUG

CKD-330 Tab.

Experimental Group 1; Placebo Group 1

Placebo of CKD-330 DRUG

Placebo of CKD-330 Tab.

Placebo Group 2

D086 DRUG

D086 Tab.

Experimental Group 1; Placebo Group 2

Placebo of D086 DRUG

Placebo of D086 Tab.

Placebo Group 1

D723 DRUG

D723 Tab.

Placebo Group 2

Placebo of D723 DRUG

Placebo of D723 Tab.

Experimental Group 1; Placebo Group 1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patients whose blood pressures measured at Visit 2 were:
• Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (16)

Dong-A University Hospital

Busan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Catholic University Seoul St. Mary's Hospital

Seoul, South Korea

Location

Hanyang University Hospital

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyunghee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Asan Medical Center

Seoul, South Korea

Location

Seoul Medical Center

Seoul, South Korea

Location

Yonsei University Medical Center Gangnam Severance Hospital

Seoul, South Korea

Location

Yonsei University Medical Center Severance Hospital

Seoul, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: July 12, 2018
• Study Start: April 4, 2018
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: July 24, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (16)