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

HK inno.N

Status and phase: Unknown; Phase 3

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Amlodipine 10mg+Valsartan 160mg; Drug: Valsartan 160mg+Atorvastatin 40mg; Drug: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03639480

CJ_EXA_301

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups

Test

Experimental group

Description:

Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Treatment:

Drug: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Reference 1

Active Comparator group

Description:

Amlodipine 10mg+Valsartan 160mg

Treatment:

Drug: Amlodipine 10mg+Valsartan 160mg

Reference 2

Active Comparator group

Description:

Valsartan 160mg+Atorvastatin 40mg

Treatment:

Drug: Valsartan 160mg+Atorvastatin 40mg