NCT04659070

To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia

A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, Randomized, double-blind, acitve-controlled, Phase 3 Clinical Trial in 8 weeks for screening, twice Investigational product administer, Follow up visit.

Detailed description

The purpose of this study is to evaluate the efficacy and safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in patients with essential hypertension and primary hypercholesterolemia.

Conditions

• Primary Hypercholesterolemia
• Hypertension

Interventions

Type	Name	Description
DRUG	Experimental : Ezetimibe / Rosuvastatin + Telmisartan	Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks
DRUG	Active comparator1 : Ezetimibe / Rosuvastatin	Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks
DRUG	Active comparator2 : Telmisartan	Telmisartan 80mg PO, Once daily for 8 weeks

Timeline

• Start date: 2020-07-15
• Primary completion: 2022-05-19
• Completion: 2022-05-19
• First posted: 2020-12-09
• Last updated: 2020-12-09

Locations

1 site across 1 country: South Korea