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NCT03639480 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03639480
Other study ID # CJ_EXA_301
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date October 13, 2017
Est. completion date October 2018

Study information
Verified date August 2018
Source CJ HealthCare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 180
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years to 74 Years
Eligibility 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%)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
• Amlodipine 10mg+Valsartan 160mg
Amlodipine 10mg+Valsartan 160mg
• Valsartan 160mg+Atorvastatin 40mg
Valsartan 160mg+Atorvastatin 40mg

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in siSBP Change in siSBP from baseline after 8 weeks of study treatment baseline and 8 weeks
Primary Change in LDL-C Change in LDL-C from baseline after 8 weeks of study treatment baseline and 8 weeks
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