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

HK inno.N Corporation203 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

203

Conditions

Hypertension With Hyperlipidemia

Interventions

Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mgDRUG

Amlodipine 10 mg + Valsartan 160 mgDRUG

Valsartan 160 mg + Rosuvastatin 20 mgDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 74 Years

Medical Language ↔ Plain English

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 %)

Outcomes

Primary Outcomes

Change of LDL-C and siSBP

Mean change from baseline in LDL-C and siSBP at Week 8

Time frame: baseline and 8 weeks

Data from ClinicalTrials.gov

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