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

Primary Purpose

Hypercholesterolemia, Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ezetimibe/Rosuvastatin
Telmisartan
Sponsored by
Addpharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Ezetimibe/Rosuvastatin and Telmisartan

Ezetimibe/Rosuvastatin

Telmisartan

Arm Description

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

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

60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2019
Last Updated
January 13, 2021
Sponsor
Addpharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03872232
Brief Title
Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
August 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ezetimibe/Rosuvastatin and Telmisartan
Arm Type
Experimental
Arm Description
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks.
Arm Title
Ezetimibe/Rosuvastatin
Arm Type
Active Comparator
Arm Description
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks.
Arm Title
Telmisartan
Arm Type
Active Comparator
Arm Description
60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe/Rosuvastatin
Other Intervention Name(s)
Rosuvamibe Tab.
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Other Intervention Name(s)
Micardis Tab.
Intervention Description
PO, Once daily(QD), 8weeks
Primary Outcome Measure Information:
Title
Low density lipoprotein cholesterol (LDL-C)
Description
LDL-C change at Week 8 compared to Baseline
Time Frame
Baseline, Week 8
Title
Mean sitting systolic blood pressure (MSSBP)
Description
MSSBP change at Week 8 compared to Baseline
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Mean sitting systolic blood pressure (MSSBP)
Description
MSSBP change at Week 4 compared to Baseline
Time Frame
Baseline, Week 4
Title
Low density lipoprotein cholesterol (LDL-C)
Description
LDL-C change at Week 4 compared to Baseline
Time Frame
Baseline, Week 4
Title
Mean sitting diastolic blood pressure (MSDBP)
Description
MSDBP change at Week 4, 8 compared to Baseline
Time Frame
Baseline, Week 4, Week 8
Title
Total Cholesterol (TC)
Description
TC change at Week 4, 8 compared to Baseline
Time Frame
Baseline, Week 4, Week 8
Title
High density lipoprotein cholesterol (HDL-C)
Description
HDL-C change at Week 4, 8 compared to Baseline
Time Frame
Baseline, Week 4, Week 8
Title
Triglyceride (TG)
Description
TG change at Week 4, 8 compared to Baseline
Time Frame
Baseline, Week 4, Week 8
Title
Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)
Description
LDL-C/HDL-C change at Week 4, 8 compared to Baseline
Time Frame
Baseline, Week 4, Week 8
Title
Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)
Description
TC/HDL-C change at Week 4,8 compared to Baseline
Time Frame
Baseline, Week 4, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Subjects with hypertension and hyperlipidemia Exclusion Criteria: Patient with known or suspected secondary hypertension Other exclusions applied
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo Soo Kim, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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