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

Primary Purpose

Hypercholesterolemia, Hypertension

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ezetimibe/Rosuvastatin

Telmisartan

Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET

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

Arm Label

Co-administered of AD-2071 and AD-2073

Co-administered of AD-2071 and AD-2072

AD-2073

Arm Description

48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.

48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.

48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks.

Outcomes

Primary Outcome Measures

Low density lipoprotein cholesterol (LDL-C)

LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073

Mean sitting systolic blood pressure (MSSBP)

MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073

Secondary Outcome Measures

Full Information

NCT ID

NCT04158076

First Posted

November 7, 2019

Last Updated

May 10, 2021

Sponsor

Addpharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04158076

Brief Title

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

Official Title

A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

January 23, 2020 (Actual)

Primary Completion Date

January 14, 2021 (Actual)

Study Completion Date

January 14, 2021 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine 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/Amlodipine in patients with primary hypercholesterolemia and essential hypertension. In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks. In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks. In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" 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

ParticipantInvestigator

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Co-administered of AD-2071 and AD-2073

Arm Type

Experimental

Arm Description

48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.

Arm Title

Co-administered of AD-2071 and AD-2072

Arm Type

Active Comparator

Arm Description

48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.

Arm Title

AD-2073

Arm Type

Active Comparator

Arm Description

48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" 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

Intervention Type

Drug

Intervention Name(s)

Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET

Other Intervention Name(s)

Twynsta

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 AD-2071 + AD-2073 with AD-2073

Time Frame

Baseline, Week 8

Title

Mean sitting systolic blood pressure (MSSBP)

Description

MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073

Time Frame

Baseline, Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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