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

A Double-blind, Randomized, Multi-center Phase III Clinical Trial 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03536598

Enrollment

203

Registered

2018-05-24

Start date

2016-10-14

Completion date

2017-09-04

Last updated

2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension With Hyperlipidemia

Brief summary

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

Interventions

DRUGAmlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg

DRUGAmlodipine 10 mg + Valsartan 160 mg

DRUGValsartan 160 mg + Rosuvastatin 20 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 74 Years

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 %)

Design outcomes

Primary

Measure	Time frame	Description
Change of LDL-C and siSBP	baseline and 8 weeks	Mean change from baseline in LDL-C and siSBP at Week 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026