Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia

Phase 3

• Conditions: Hyperlipidemia; Hypertension
• Interventions: Drug: Valsartan 160mg+Atorvastatin 40mg; Drug: Amlodipine 10mg+Valsartan 160mg; Drug: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

• Registration Number: NCT03639480
• Lead Sponsor: HK inno.N Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-13
• Status Verified: 2018-08
• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-19
• Last Update Submitted: 2018-08-19
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference 2	Valsartan 160mg+Atorvastatin 40mg	Valsartan 160mg+Atorvastatin 40mg
Reference 1	Amlodipine 10mg+Valsartan 160mg	Amlodipine 10mg+Valsartan 160mg
Test	Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg	Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Primary Outcome Measures

Name	Time	Method
Change in LDL-C	baseline and 8 weeks	Change in LDL-C from baseline after 8 weeks of study treatment
Change in siSBP	baseline and 8 weeks	Change in siSBP from baseline after 8 weeks of study treatment

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of