Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides

JW Pharmaceutical

Status and phase: Active, not recruiting; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo (for Pitavastatin/Ezetimibe); Drug: Ezetimibe 10 mg; Drug: Placebo (for Pitavastatin); Drug: Pitavastatin 4mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07442630

JW22401

Details and patient eligibility

About

A multicenter, randomized, double-blind, phase Ⅳ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides

Full description

A multicenter study to evaluate efficacy and safety

Enrollment: 88 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hypercholesterolemia
• Patients diagnosed with metabolic syndrome or type 2 diabetes mellitus, and presenting with elevated LDL-C

Exclusion criteria

• New-onset acute cardio-cerebrovascular disease
• Severe hepatic impairment
• Active liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

Pitavastatin/Ezetimibe Combination

Experimental group

Description:

FDC of Pitavastatin/Ezetimibe

Treatment:

Drug: Pitavastatin 4mg

Drug: Placebo (for Pitavastatin)

Drug: Ezetimibe 10 mg

Pitavastatin Monotherapy

Active Comparator group

Description:

Pitavastatin

Treatment:

Drug: Pitavastatin 4mg

Drug: Placebo (for Pitavastatin/Ezetimibe)