search
Back to results

Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

Primary Purpose

Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Temisartan+Amlodipine+Rosuvastatin (Combination drug)
Temisartan+Amlodipine
Temisartan+Rosuvastatin
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  1. Signed informed consent
  2. Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

  1. Patients with known or suspected secondary hypertension
  2. Other exclusions applied

Sites / Locations

  • Seoul Natuional University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

"Combination drug:Temisartan+Amlodipine+Rosuvastatin"

Temisartan+Amlodipine

Temisartan+Rosuvastatin

Arm Description

60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.

60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.

60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.

Outcomes

Primary Outcome Measures

Mean sitting systolic blood pressure (MSSBP)
MSSBP change form the baseline at Week 8
Low density lipoprotein cholesterol (LDL-C)
LDL-C change form the baseline at Week 8

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2017
Last Updated
January 14, 2019
Sponsor
Yuhan Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03067688
Brief Title
Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia
Official Title
A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Temisartan/Amlodipine and Rosuvastatin in Subjects With Hypertension and Hyperlipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
March 27, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

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
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.
Detailed Description
This trial is a phase 3 study to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia. In "Temisartan/Amlodipine/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine/Rosuvastatin" 8 for weeks. In "Temisartan/Amlodipine" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine" for 8 weeks. In "Temisartan/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Rosuvastatin" for 8 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double Blind
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Combination drug:Temisartan+Amlodipine+Rosuvastatin"
Arm Type
Experimental
Arm Description
60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.
Arm Title
Temisartan+Amlodipine
Arm Type
Active Comparator
Arm Description
60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.
Arm Title
Temisartan+Rosuvastatin
Arm Type
Active Comparator
Arm Description
60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Temisartan+Amlodipine+Rosuvastatin (Combination drug)
Other Intervention Name(s)
Twynsta Tab.+Crestor Tab.
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
Temisartan+Amlodipine
Other Intervention Name(s)
Twynsta Tab.
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
Temisartan+Rosuvastatin
Other Intervention Name(s)
Micardis Tab.+Crestor Tab.
Intervention Description
PO, Once daily(QD), 8weeks
Primary Outcome Measure Information:
Title
Mean sitting systolic blood pressure (MSSBP)
Description
MSSBP change form the baseline at Week 8
Time Frame
Baseline, Week 8
Title
Low density lipoprotein cholesterol (LDL-C)
Description
LDL-C change form the baseline at Week 8
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
MSSBP (Mean sitting systolic blood pressure)
Description
MSSBP change form the baseline at Week 4
Time Frame
Baseline, Week 4
Title
Mean sitting diastolic blood pressure (MSDBP)
Description
MSDBP change form the baseline at Week 4, 8
Time Frame
Baseline, Week 4, Week 8
Title
Low density lipoprotein cholesterol (LDL-C)
Description
LDL-C change form the baseline at Week 4
Time Frame
Baseline, Week 4
Title
Total Cholesterol (TC)
Description
TC change form the baseline at Week 4, 8
Time Frame
Baseline, Week 4, Week 8
Title
High density lipoprotein cholesterol (HDL-C)
Description
HDL-C change form the baseline at Week 4, 8
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 form the baseline at Week 4, 8
Time Frame
Baseline, Week 4, Week 8
Title
Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)
Description
TC/HDL-C change form the baseline at Week 4, 8
Time Frame
Baseline, Week 4, Week 8
Title
Triglyceride (TG)
Description
TG change form the baseline at Week 4, 8
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: Patients with known or suspected secondary hypertension Other exclusions applied
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunhee Na, MD
Organizational Affiliation
Yuhan Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Seoul Natuional University Hospital
City
Seoul
State/Province
Jongno
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32937023
Citation
Jin X, Kim MH, Han KH, Hong SJ, Ahn JC, Sung JH, Cho JM, Lee HC, Choi SY, Lee K, Kim WS, Rhee MY, Kim JH, Hong SP, Yoo BS, Cho EJ, Lee JH, Kim PJ, Park CG, Hyon MS, Shin JH, Lee SH, Sung KC, Hwang J, Kwon K, Chae IH, Seo JS, Kim H, Lee H, Cho Y, Kim HS. Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia. J Clin Hypertens (Greenwich). 2020 Oct;22(10):1835-1845. doi: 10.1111/jch.13893. Epub 2020 Sep 16.
Results Reference
derived

Learn more about this trial

Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

We'll reach out to this number within 24 hrs