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

NCT ID: NCT03067688

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-11

Study Completion Date

2018-03-27

Brief Summary

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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

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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.

Conditions

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Hypertension Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double Blind

Study Groups

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"Combination drug:Temisartan+Amlodipine+Rosuvastatin"

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

Group Type EXPERIMENTAL

Temisartan+Amlodipine+Rosuvastatin (Combination drug)

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Temisartan+Amlodipine

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

Group Type ACTIVE_COMPARATOR

Temisartan+Amlodipine

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Temisartan+Rosuvastatin

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

Group Type ACTIVE_COMPARATOR

Temisartan+Rosuvastatin

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Interventions

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Temisartan+Amlodipine+Rosuvastatin (Combination drug)

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Temisartan+Amlodipine

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Temisartan+Rosuvastatin

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Other Intervention Names

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Twynsta Tab.+Crestor Tab. Twynsta Tab. Micardis Tab.+Crestor Tab.

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyunhee Na, MD

Role: STUDY_DIRECTOR

Yuhan Corporation

Locations

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Seoul Natuional University Hospital

Seoul, Jongno, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32937023 (View on PubMed)

Other Identifiers

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YHP1604-301

Identifier Type: -

Identifier Source: org_study_id

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