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

Phase 3

Completed

• Conditions: Hypertension With Hyperlipidemia
• Interventions: Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg; Drug: Amlodipine 10 mg + Valsartan 160 mg; Drug: Valsartan 160 mg + Rosuvastatin 20 mg

• Registration Number: NCT03536598
• Lead Sponsor: HK inno.N Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-14
• Status Verified: 2017-07
• Study First Submitted: 2017-07-18
• Primary Completion: 2017-09-04
• Study Completion: 2017-09-04
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Last Update Submitted: 2018-05-28
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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 %)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg	Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg
Reference 1	Amlodipine 10 mg + Valsartan 160 mg	Amlodipine 10mg + Valsartan 160mg
Reference 2	Valsartan 160 mg + Rosuvastatin 20 mg	Valsartan 160mg + Rosuvastatin 20mg

Primary Outcome Measures

Name	Time	Method
Change of LDL-C and siSBP	baseline and 8 weeks	Mean change from baseline in LDL-C and siSBP at Week 8