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

January 13, 2021 updated by: Addpharma Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ezetimibe/Rosuvastatin and Telmisartan
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks.
Drug: Telmisartan
PO, Once daily(QD), 8weeks
Other Names:
  • Micardis Tab.
Drug: Ezetimibe/Rosuvastatin
PO, Once daily(QD), 8weeks
Other Names:
  • Rosuvamibe Tab.
Active Comparator: Ezetimibe/Rosuvastatin
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks.
Drug: Ezetimibe/Rosuvastatin
PO, Once daily(QD), 8weeks
Other Names:
  • Rosuvamibe Tab.
Active Comparator: Telmisartan
60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.
Drug: Telmisartan
PO, Once daily(QD), 8weeks
Other Names:
  • Micardis Tab.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: Hyo Soo Kim, M.D., Ph.D, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

August 12, 2020

Study Completion (Actual)

August 12, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROZETEL_RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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