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

Hypertension With Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536598
• Other study ID #: CJ_EXR_301
• Status: Completed
• Phase: Phase 3
• Start date: October 14, 2016
• Est. completion date: September 4, 2017

Study information

• Verified date: July 2017
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: September 4, 2017
• Est. primary completion date: September 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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 %)

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension With Hyperlipidemia

Intervention

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

• Amlodipine 10 mg + Valsartan 160 mg

• Valsartan 160 mg + Rosuvastatin 20 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Outcome

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