Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan

Addpharma

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hypercholesterolemia

Treatments: Drug: Telmisartan; Drug: Ezetimibe/Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03872232

ROZETEL_RCT

Details and patient eligibility

About

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

Full description

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.

In "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.

Enrollment: 180 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Subjects with hypertension and hyperlipidemia

Exclusion criteria

• Patient with known or suspected secondary hypertension
• Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups

Ezetimibe/Rosuvastatin and Telmisartan

Experimental group

Description:

60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks.

Treatment:

Drug: Ezetimibe/Rosuvastatin

Drug: Telmisartan

Ezetimibe/Rosuvastatin

Active Comparator group

Description:

60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks.

Treatment:

Drug: Ezetimibe/Rosuvastatin

Telmisartan

Active Comparator group

Description:

60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.

Treatment:

Drug: Telmisartan