NCT03103256

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 17, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

March 22, 2017

Last Update Submit

September 6, 2018

Conditions

Hypertension and Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • Percent change of LDL-Cholesterol

    LDL-Cholesterol

    0, 8 weeks

  • Change of mean seated Systolic Blood Pressure

    Blood Pressure

    0, 8 weeks

Study Arms (3)

YHP1701

EXPERIMENTAL

PO, Once daily (QD), 8 weeks

Drug: YHP1701

YHR1703

ACTIVE COMPARATOR

PO, Once daily (QD), 8 weeks

Drug: YHR1703

YHR1704

ACTIVE COMPARATOR

PO, Once daily (QD), 8 weeks

Drug: YHR1704

Interventions

YHP1701DRUG

PO, Once daily (QD), 8 weeks

YHP1701
YHR1703DRUG

PO, Once daily (QD), 8 weeks

YHR1703
YHR1704DRUG

PO, Once daily (QD), 8 weeks

YHR1704

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32003938DERIVED

MeSH Terms

Conditions

HypertensionHyperlipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Andrew Lee

    Yuhan Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 6, 2017

Study Start

May 17, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

September 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)