Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

Yuhan

Status and phase: Completed; Phase 3

Conditions: Hypertension and Hyperlipidemia

Treatments: Drug: YHR1703; Drug: YHP1701; Drug: YHR1704

Study type: Interventional

Funder types: Industry

Identifiers

NCT03103256

YHP1701-301

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 3 patient groups

YHP1701

Experimental group

Description:

PO, Once daily (QD), 8 weeks

Treatment:

Drug: YHP1701

YHR1703

Active Comparator group

Description:

PO, Once daily (QD), 8 weeks

Treatment:

Drug: YHR1703

YHR1704

Active Comparator group

Description:

PO, Once daily (QD), 8 weeks

Treatment:

Drug: YHR1704