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

August 19, 2018 updated by: HK inno.N Corporation

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

17 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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+Atorvastatin 40mg
Drug: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Active Comparator: Reference 1
Amlodipine 10mg+Valsartan 160mg
Drug: Amlodipine 10mg+Valsartan 160mg
Amlodipine 10mg+Valsartan 160mg
Active Comparator: Reference 2
Valsartan 160mg+Atorvastatin 40mg
Drug: Valsartan 160mg+Atorvastatin 40mg
Valsartan 160mg+Atorvastatin 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in siSBP
Time Frame: baseline and 8 weeks
Change in siSBP from baseline after 8 weeks of study treatment
baseline and 8 weeks
Change in LDL-C
Time Frame: baseline and 8 weeks
Change in LDL-C from baseline after 8 weeks of study treatment
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: Duk-Hyun Kang, Ph.D, Asan Medical Center

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 13, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 19, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 19, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJ_EXA_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.

Clinical Trials on Hypertension

Clinical Trials on Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe