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

Phase 3

Completed

• Conditions: Hypertension; Hypercholesterolemia
• Interventions: Drug: Ezetimibe/Rosuvastatin; Drug: Telmisartan

• Registration Number: NCT03872232
• Lead Sponsor: Addpharma Inc.

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.

Study Timeline

• Study Start: 2019-02-26
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Primary Completion: 2020-08-12
• Study Completion: 2020-08-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Signed informed consent
• Subjects with hypertension and hyperlipidemia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean sitting diastolic blood pressure (MSDBP)	Baseline, Week 4, Week 8	MSDBP 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
Total Cholesterol (TC)	Baseline, Week 4, Week 8	TC change at Week 4, 8 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
Mean sitting systolic blood pressure (MSSBP)	Baseline, Week 4	MSSBP change at Week 4 compared to Baseline
High density lipoprotein cholesterol (HDL-C)	Baseline, Week 4, Week 8	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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of