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Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03103256
Enrollment
106
Registered
2017-04-06
Start date
2017-05-17
Completion date
2018-04-30
Last updated
2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension and Hyperlipidemia

Brief summary

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

Interventions

DRUGYHP1701

PO, Once daily (QD), 8 weeks

DRUGYHR1703

PO, Once daily (QD), 8 weeks

DRUGYHR1704

PO, Once daily (QD), 8 weeks

Sponsors

Yuhan Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent change of LDL-Cholesterol0, 8 weeksLDL-Cholesterol
Change of mean seated Systolic Blood Pressure0, 8 weeksBlood Pressure

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026