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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2018-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hypertension Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test

Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Group Type EXPERIMENTAL

Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Intervention Type DRUG

Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Reference 1

Amlodipine 10mg+Valsartan 160mg

Group Type ACTIVE_COMPARATOR

Amlodipine 10mg+Valsartan 160mg

Intervention Type DRUG

Amlodipine 10mg+Valsartan 160mg

Reference 2

Valsartan 160mg+Atorvastatin 40mg

Group Type ACTIVE_COMPARATOR

Valsartan 160mg+Atorvastatin 40mg

Intervention Type DRUG

Valsartan 160mg+Atorvastatin 40mg

Interventions

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Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Intervention Type DRUG

Amlodipine 10mg+Valsartan 160mg

Intervention Type DRUG

Valsartan 160mg+Atorvastatin 40mg

Intervention Type DRUG

Eligibility Criteria

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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%)

Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No