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Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia

Primary Purpose

Hypertension With Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg
Amlodipine 10 mg + Valsartan 160 mg
Valsartan 160 mg + Rosuvastatin 20 mg
Sponsored by
HK inno.N Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension With Hyperlipidemia

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged between 19 and 74 years
  • Patient with dyslipidemia and hypertension

Exclusion Criteria:

  • At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
  • At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg
  • Secodary hypertension
  • Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Test

    Reference 1

    Reference 2

    Arm Description

    Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg

    Amlodipine 10mg + Valsartan 160mg

    Valsartan 160mg + Rosuvastatin 20mg

    Outcomes

    Primary Outcome Measures

    Change of LDL-C and siSBP
    Mean change from baseline in LDL-C and siSBP at Week 8

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2017
    Last Updated
    May 28, 2018
    Sponsor
    HK inno.N Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03536598
    Brief Title
    Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia
    Official Title
    A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 14, 2016 (Actual)
    Primary Completion Date
    September 4, 2017 (Actual)
    Study Completion Date
    September 4, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    HK inno.N Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension With Hyperlipidemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    203 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test
    Arm Type
    Experimental
    Arm Description
    Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg
    Arm Title
    Reference 1
    Arm Type
    Active Comparator
    Arm Description
    Amlodipine 10mg + Valsartan 160mg
    Arm Title
    Reference 2
    Arm Type
    Active Comparator
    Arm Description
    Valsartan 160mg + Rosuvastatin 20mg
    Intervention Type
    Drug
    Intervention Name(s)
    Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Amlodipine 10 mg + Valsartan 160 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Valsartan 160 mg + Rosuvastatin 20 mg
    Primary Outcome Measure Information:
    Title
    Change of LDL-C and siSBP
    Description
    Mean change from baseline in LDL-C and siSBP at Week 8
    Time Frame
    baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged between 19 and 74 years Patient with dyslipidemia and hypertension Exclusion Criteria: At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg Secodary hypertension Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dong Ju Choi, Ph.D
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia

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