Back to resultsStudy to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia
Primary Purpose
Hypertension, Hyperlipidemia
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Amlodipine 10mg+Valsartan 160mg
Valsartan 160mg+Atorvastatin 40mg
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Aged between 19 and 74 years
- Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanying hyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)
- Decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study
Exclusion Criteria:
- Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg at Visit 1(screening)
- The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP
- LDL-C > 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)
- Secondary hypertension
- Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulin therapy or patients with HbA1c ≥ 9%)
Sites / Locations
- Asan Medical Center
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+Atorvastatin 40mg
Amlodipine 10mg+Valsartan 160mg
Valsartan 160mg+Atorvastatin 40mg
Outcomes
Primary Outcome Measures
Change in siSBP
Change in siSBP from baseline after 8 weeks of study treatment
Change in LDL-C
Change in LDL-C from baseline after 8 weeks of study treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03639480
Brief Title
Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia
Official Title
A Double-blind, Randomized, Multi-center Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of CJ-30061 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Atorvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
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-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin 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, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
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+Atorvastatin 40mg
Intervention Type
Drug
Intervention Name(s)
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Intervention Description
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Intervention Type
Drug
Intervention Name(s)
Amlodipine 10mg+Valsartan 160mg
Intervention Description
Amlodipine 10mg+Valsartan 160mg
Intervention Type
Drug
Intervention Name(s)
Valsartan 160mg+Atorvastatin 40mg
Intervention Description
Valsartan 160mg+Atorvastatin 40mg
Primary Outcome Measure Information:
Title
Change in siSBP
Description
Change in siSBP from baseline after 8 weeks of study treatment
Time Frame
baseline and 8 weeks
Title
Change in LDL-C
Description
Change in LDL-C from baseline after 8 weeks of study treatment
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
Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanying hyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)
Decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study
Exclusion Criteria:
Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg at Visit 1(screening)
The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP
LDL-C > 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)
Secondary hypertension
Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulin therapy or patients with HbA1c ≥ 9%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk-Hyun Kang, Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia
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