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

May 28, 2018 updated by: HK inno.N Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg
Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg
Active Comparator: Reference 1
Amlodipine 10mg + Valsartan 160mg
Drug: Amlodipine 10 mg + Valsartan 160 mg
Active Comparator: Reference 2
Valsartan 160mg + Rosuvastatin 20mg
Drug: Valsartan 160 mg + Rosuvastatin 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of LDL-C and siSBP
Time Frame: baseline and 8 weeks
Mean change from baseline in LDL-C and siSBP at Week 8
baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HK inno.N Corporation

Investigators

  • Principal Investigator: Dong Ju Choi, Ph.D, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2016

Primary Completion (Actual)

September 4, 2017

Study Completion (Actual)

September 4, 2017

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 24, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJ_EXR_301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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