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

A Double-blind, Randomized, Multi-center Phase 3 Clinical Trial 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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03639480

Enrollment

180

Registered

2018-08-21

Start date

2017-10-13

Completion date

2018-10-31

Last updated

2018-08-21

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

Conditions

Hyperlipidemia, Hypertension

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

Interventions

DRUGAmlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

DRUGAmlodipine 10mg+Valsartan 160mg

Amlodipine 10mg+Valsartan 160mg

DRUGValsartan 160mg+Atorvastatin 40mg

Valsartan 160mg+Atorvastatin 40mg

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 * 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%)

Design outcomes

Primary

Measure	Time frame	Description
Change in siSBP	baseline and 8 weeks	Change in siSBP from baseline after 8 weeks of study treatment
Change in LDL-C	baseline and 8 weeks	Change in LDL-C from baseline after 8 weeks of study treatment

Countries

South Korea

Outcome results

None listed

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