NCT03067688

Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Temisartan/Amlodipine and Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.

Detailed description

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia. In "Temisartan/Amlodipine/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine/Rosuvastatin" 8 for weeks. In "Temisartan/Amlodipine" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine" for 8 weeks. In "Temisartan/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Rosuvastatin" for 8 weeks.

Conditions

• Hypertension
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Temisartan+Amlodipine+Rosuvastatin (Combination drug)	PO, Once daily(QD), 8weeks
DRUG	Temisartan+Amlodipine	PO, Once daily(QD), 8weeks
DRUG	Temisartan+Rosuvastatin	PO, Once daily(QD), 8weeks

Timeline

• Start date: 2017-04-11
• Primary completion: 2018-03-27
• Completion: 2018-03-27
• First posted: 2017-03-01
• Last updated: 2019-01-16

Locations

1 site across 1 country: South Korea