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Completed

NCT Number: NCT03583905

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

To Evaluate the Efficacy and Safety of CKD-333

Completed

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Key information

Conditions

Hypertensive Patients With Dyslipidemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dong-A University Hospital, Busan, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CKD-330

Drug

CKD-330 Tab.

Placebo of CKD-330

Drug

Placebo of CKD-330 Tab.

D086

Drug

D086 Tab.

Placebo of D086

Drug

Placebo of D086 Tab.

D723

Drug

D723 Tab.

Placebo of D723

Drug

Placebo of D723 Tab.

Primary outcomes

  1. Change rate from baseline in LDL-C

    Time frame: 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

  2. Change from baseline in MSSBP

    Time frame: 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 2

Secondary outcomes

  1. Change rate from baseline in LDL-C

    Time frame: 4 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

  2. Change from baseline in LDL-C

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

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

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

  4. Change from baseline in MSSBP(mmHg)

    Time frame: 4 weeks after drug administrations

    Compare experimental group 1 with placebo group 2

  5. Change from baseline in MSDBP

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 2

  6. Attainment of normal blood pressure as defined by JNC Ⅶ

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 2

  7. Change from baseline in TC

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

  8. Change from baseline in TG

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

  9. Change from baseline in HDL-C

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

  10. change rate from baseline in TC

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

  11. change rate from baseline in TG

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

  12. change rate from baseline in HDL-C

    Time frame: 4, 8 weeks after drug administrations

    Compare experimental group 1 with placebo group 1

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2018
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.