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

HK inno.N

Status and phase: Completed; Phase 3

Conditions: Hypertension With Hyperlipidemia

Treatments: Drug: Valsartan 160 mg + Rosuvastatin 20 mg; Drug: Amlodipine 10 mg + Valsartan 160 mg; Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03536598

CJ_EXR_301

Details and patient eligibility

About

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

Enrollment: 203 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No 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 %)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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203 participants in 3 patient groups

Test

Experimental group

Description:

Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg

Treatment:

Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg

Reference 1

Active Comparator group

Description:

Amlodipine 10mg + Valsartan 160mg

Treatment:

Drug: Amlodipine 10 mg + Valsartan 160 mg

Reference 2

Active Comparator group

Description:

Valsartan 160mg + Rosuvastatin 20mg

Treatment:

Drug: Valsartan 160 mg + Rosuvastatin 20 mg