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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872232
• Other study ID #: ROZETEL_RCT
• Status: Completed
• Phase: Phase 3
• Start date: February 26, 2019
• Est. completion date: August 12, 2020

Study information

• Verified date: January 2021
• Source: Addpharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

• Patient with known or suspected secondary hypertension

• Other exclusions applied

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertension

Intervention

Drug:
• Ezetimibe/Rosuvastatin
PO, Once daily(QD), 8weeks
• Telmisartan
PO, Once daily(QD), 8weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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