Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia
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
1 other identifier
interventional
180
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2017
CompletedFirst Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedAugust 21, 2018
August 1, 2018
12 months
August 9, 2018
August 19, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Change in siSBP
Change in siSBP from baseline after 8 weeks of study treatment
baseline and 8 weeks
Change in LDL-C
Change in LDL-C from baseline after 8 weeks of study treatment
baseline and 8 weeks
Study Arms (3)
Test
EXPERIMENTALAmlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Reference 1
ACTIVE COMPARATORAmlodipine 10mg+Valsartan 160mg
Reference 2
ACTIVE COMPARATORValsartan 160mg+Atorvastatin 40mg
Interventions
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duk-Hyun Kang, Ph.D
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 21, 2018
Study Start
October 13, 2017
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
August 21, 2018
Record last verified: 2018-08