Back to results

Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

Primary Purpose

Hypertension and Hyperlipidemia

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YHP1701

YHR1703

YHR1704

About this trial

This is an interventional treatment trial for Hypertension and Hyperlipidemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

YHP1701

YHR1703

YHR1704

Arm Description

PO, Once daily (QD), 8 weeks

Outcomes

Primary Outcome Measures

Percent change of LDL-Cholesterol

LDL-Cholesterol

Change of mean seated Systolic Blood Pressure

Blood Pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT03103256

First Posted

March 22, 2017

Last Updated

September 6, 2018

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03103256

Brief Title

Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

May 17, 2017 (Actual)

Primary Completion Date

April 30, 2018 (Actual)

Study Completion Date

April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension and Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YHP1701

Arm Type

Experimental

Arm Description

PO, Once daily (QD), 8 weeks

Arm Title

YHR1703

Arm Type

Active Comparator

Arm Description

PO, Once daily (QD), 8 weeks

Arm Title

YHR1704

Arm Type

Active Comparator

Arm Description

PO, Once daily (QD), 8 weeks

Intervention Type

Drug

Intervention Name(s)

YHP1701

Intervention Description

PO, Once daily (QD), 8 weeks

Intervention Type

Drug

Intervention Name(s)

YHR1703

Intervention Description

PO, Once daily (QD), 8 weeks

Intervention Type

Drug

Intervention Name(s)

YHR1704

Intervention Description

PO, Once daily (QD), 8 weeks

Primary Outcome Measure Information:

Title

Percent change of LDL-Cholesterol

Description

LDL-Cholesterol

Time Frame

0, 8 weeks

Title

Change of mean seated Systolic Blood Pressure

Description

Blood Pressure

Time Frame

0, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Lee

Organizational Affiliation

Yuhan Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Seoul Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32003938

Citation

Kim W, Chang K, Cho EJ, Ahn JC, Yu CW, Cho KI, Kim YJ, Kang DH, Kim SY, Lee SH, Kim U, Kim SJ, Ahn YK, Lee CH, Shin JH, Kim M, Park CG. A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension. J Clin Hypertens (Greenwich). 2020 Feb;22(2):261-269. doi: 10.1111/jch.13774. Epub 2020 Jan 31.

Results Reference

derived

Learn more about this trial

Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

We'll reach out to this number within 24 hrs