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

Addpharma Inc.180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Hypercholesterolemia Hypertension

Interventions

Ezetimibe/RosuvastatinDRUG

PO, Once daily(QD), 8weeks

TelmisartanDRUG

PO, Once daily(QD), 8weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent * Subjects with hypertension and hyperlipidemia Exclusion Criteria: * Patient with known or suspected secondary hypertension * Other exclusions applied

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Low density lipoprotein cholesterol (LDL-C)

LDL-C change at Week 8 compared to Baseline

Time frame: Baseline, Week 8

Mean sitting systolic blood pressure (MSSBP)

MSSBP change at Week 8 compared to Baseline

Time frame: Baseline, Week 8

Secondary Outcomes

Mean sitting systolic blood pressure (MSSBP)

MSSBP change at Week 4 compared to Baseline

Time frame: Baseline, Week 4

Low density lipoprotein cholesterol (LDL-C)

LDL-C change at Week 4 compared to Baseline

Time frame: Baseline, Week 4

Mean sitting diastolic blood pressure (MSDBP)

MSDBP change at Week 4, 8 compared to Baseline

Time frame: Baseline, Week 4, Week 8

Total Cholesterol (TC)

TC change at Week 4, 8 compared to Baseline

Time frame: Baseline, Week 4, Week 8

High density lipoprotein cholesterol (HDL-C)

HDL-C change at Week 4, 8 compared to Baseline

Time frame: Baseline, Week 4, Week 8

Triglyceride (TG)

TG change at Week 4, 8 compared to Baseline

Time frame: Baseline, Week 4, Week 8

Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)

Data from ClinicalTrials.gov

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