Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

Hypertension and Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103256
• Other study ID #: YHP1701-301
• Status: Completed
• Phase: Phase 3
• Start date: May 17, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: September 2018
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension
• Hypertension and Hyperlipidemia

Intervention

Drug:
• YHP1701
PO, Once daily (QD), 8 weeks
• YHR1703
PO, Once daily (QD), 8 weeks
• YHR1704
PO, Once daily (QD), 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change of LDL-Cholesterol	LDL-Cholesterol	0, 8 weeks
Primary	Change of mean seated Systolic Blood Pressure	Blood Pressure	0, 8 weeks