Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

Phase 3

Completed

• Conditions: Hypertension and Hyperlipidemia
• Interventions: Drug: YHR1703; Drug: YHR1704; Drug: YHP1701

• Registration Number: NCT03103256
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-06
• Study Start: 2017-05-17
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YHR1703	YHR1703	PO, Once daily (QD), 8 weeks
YHR1704	YHR1704	PO, Once daily (QD), 8 weeks
YHP1701	YHP1701	PO, Once daily (QD), 8 weeks

Primary Outcome Measures

Name	Time	Method
Change of mean seated Systolic Blood Pressure	0, 8 weeks	Blood Pressure
Percent change of LDL-Cholesterol	0, 8 weeks	LDL-Cholesterol

Trial Locations

Locations (1)

Seoul Medical Center; 🇰🇷 Seoul, Korea, Republic of