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

A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan in Patients With Primary Hypercholesterolemia and Essential Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03872232

Enrollment

180

Registered

2019-03-13

Start date

2019-02-26

Completion date

2020-08-12

Last updated

2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, Hypertension

Brief summary

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.

Detailed 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.

Interventions

DRUGEzetimibe/Rosuvastatin

PO, Once daily(QD), 8weeks

DRUGTelmisartan

PO, Once daily(QD), 8weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Signed informed consent * Subjects with hypertension and hyperlipidemia

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Low density lipoprotein cholesterol (LDL-C)	Baseline, Week 8	LDL-C change at Week 8 compared to Baseline
Mean sitting systolic blood pressure (MSSBP)	Baseline, Week 8	MSSBP change at Week 8 compared to Baseline

Secondary

Measure	Time frame	Description
Mean sitting diastolic blood pressure (MSDBP)	Baseline, Week 4, Week 8	MSDBP change at Week 4, 8 compared to Baseline
Total Cholesterol (TC)	Baseline, Week 4, Week 8	TC change at Week 4, 8 compared to Baseline
High density lipoprotein cholesterol (HDL-C)	Baseline, Week 4, Week 8	HDL-C change at Week 4, 8 compared to Baseline
Mean sitting systolic blood pressure (MSSBP)	Baseline, Week 4	MSSBP change at Week 4 compared to Baseline
Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)	Baseline, Week 4, Week 8	LDL-C/HDL-C change at Week 4, 8 compared to Baseline
Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)	Baseline, Week 4, Week 8	TC/HDL-C change at Week 4,8 compared to Baseline
Triglyceride (TG)	Baseline, Week 4, Week 8	TG change at Week 4, 8 compared to Baseline
Low density lipoprotein cholesterol (LDL-C)	Baseline, Week 4	LDL-C change at Week 4 compared to Baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026