Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

September 6, 2018 updated by: Yuhan Corporation

A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP1701 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension

The purpose of this study is to determine superiority of YHP1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both man and woman who is over 19 years old
  • Patient with dyslipidemia and hypertension

Exclusion Criteria:

  • sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
  • A history of cardiovascular disease
  • Rhabdomyolysis, myopathy
  • Hypertension or hypercholesterolemia due to secondary causes
  • Uncontrolled diabetes
  • Evidence of hepatic or renal disease

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: YHP1701
PO, Once daily (QD), 8 weeks
Drug: YHP1701
PO, Once daily (QD), 8 weeks
ACTIVE_COMPARATOR: YHR1703
PO, Once daily (QD), 8 weeks
Drug: YHR1703
PO, Once daily (QD), 8 weeks
ACTIVE_COMPARATOR: YHR1704
PO, Once daily (QD), 8 weeks
Drug: YHR1704
PO, Once daily (QD), 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change of LDL-Cholesterol
Time Frame: 0, 8 weeks
LDL-Cholesterol
0, 8 weeks
Change of mean seated Systolic Blood Pressure
Time Frame: 0, 8 weeks
Blood Pressure
0, 8 weeks

Collaborators and Investigators

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

Sponsor

Yuhan Corporation

Investigators

  • Study Director: Andrew Lee, Yuhan Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 17, 2017

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

April 30, 2018

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (ACTUAL)

April 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHP1701-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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