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Completed

NCT Number: NCT03103256

Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

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

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Key information

Conditions

Hypertension and Hyperlipidemia Cardiovascular Diseases Dyslipidemias Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YHP1701

Drug

PO, Once daily (QD), 8 weeks

YHR1703

Drug

PO, Once daily (QD), 8 weeks

YHR1704

Drug

PO, Once daily (QD), 8 weeks

Primary outcomes

  1. Percent change of LDL-Cholesterol

    Time frame: 0, 8 weeks

    LDL-Cholesterol

  2. Change of mean seated Systolic Blood Pressure

    Time frame: 0, 8 weeks

    Blood Pressure

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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