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

NCT ID: NCT03536598

Last Updated: 2018-05-30

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-14

Study Completion Date

2017-09-04

Brief Summary

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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

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Conditions

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Hypertension With 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 + Rosuvastatin 20mg

Group Type EXPERIMENTAL

Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg

Intervention Type DRUG

Reference 1

Amlodipine 10mg + Valsartan 160mg

Group Type ACTIVE_COMPARATOR

Amlodipine 10 mg + Valsartan 160 mg

Intervention Type DRUG

Reference 2

Valsartan 160mg + Rosuvastatin 20mg

Group Type ACTIVE_COMPARATOR

Valsartan 160 mg + Rosuvastatin 20 mg

Intervention Type DRUG

Interventions

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Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg

Intervention Type DRUG

Amlodipine 10 mg + Valsartan 160 mg

Intervention Type DRUG

Valsartan 160 mg + Rosuvastatin 20 mg

Intervention Type DRUG

Eligibility Criteria

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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 %)
Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dong Ju Choi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Other Identifiers

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CJ_EXR_301

Identifier Type: -

Identifier Source: org_study_id

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