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

January 14, 2019 updated by: Yuhan Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

202

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

  • Korea, Republic of
    • Jongno
      • Seoul, Jongno, Korea, Republic of, 03080
        • Seoul Natuional University Hospital

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

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "Combination drug:Temisartan+Amlodipine+Rosuvastatin"
60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.
Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug)
PO, Once daily(QD), 8weeks
Other Names:
  • Twynsta Tab.+Crestor Tab.
Active Comparator: Temisartan+Amlodipine
60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.
Drug: Temisartan+Amlodipine
PO, Once daily(QD), 8weeks
Other Names:
  • Twynsta Tab.
Active Comparator: Temisartan+Rosuvastatin
60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.
Drug: Temisartan+Rosuvastatin
PO, Once daily(QD), 8weeks
Other Names:
  • Micardis Tab.+Crestor Tab.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Yuhan Corporation

Investigators

  • Study Director: Hyunhee Na, MD, Yuhan Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 11, 2017

Primary Completion (Actual)

March 27, 2018

Study Completion (Actual)

March 27, 2018

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHP1604-301

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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