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

Yuhan

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug); Drug: Temisartan+Amlodipine; Drug: Temisartan+Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03067688

YHP1604-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent
2. Subjects with hypertension and hyperlipidemia

Exclusion criteria

1. Patients with known or suspected secondary hypertension
2. Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 3 patient groups

"Combination drug:Temisartan+Amlodipine+Rosuvastatin"

Experimental group

Description:

60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.

Treatment:

Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug)

Temisartan+Amlodipine

Active Comparator group

Description:

60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.

Treatment:

Drug: Temisartan+Amlodipine

Temisartan+Rosuvastatin

Active Comparator group

Description:

60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.

Treatment:

Drug: Temisartan+Rosuvastatin