HypertensionPhase 3NCT03067688

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

A Phase 3 study testing Temisartan+Amlodipine+Rosuvastatin (Combination drug), Temisartan+Amlodipine and Temisartan+Rosuvastatin in people with Hypertension and Hyperlipidemia, run by Yuhan Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Hypertension, Hyperlipidemia
What is being tested?: Temisartan+Amlodipine+Rosuvastatin (Combination drug), Temisartan+Amlodipine and Temisartan+Rosuvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: 1 siteSouth Korea
Study dates: 11 Apr 2017to 27 Mar 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent
Subjects with hypertension and hyperlipidemia

Who cannot join

Patients with known or suspected secondary hypertension
Other exclusions applied

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul Natuional University Hospital
Seoul, Jongno, 03080

Other trials in South Korea

About this study

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

Read the 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.

Conditions: Hypertension, Hyperlipidemia
Being tested: Temisartan+Amlodipine+Rosuvastatin (Combination drug), Temisartan+Amlodipine, Temisartan+Rosuvastatin
Medical subject headings: Hypertension, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Temisartan+Amlodipine+Rosuvastatin (Combination drug)Drug
Also called Twynsta Tab.+Crestor Tab.
PO, Once daily(QD), 8weeks
Temisartan+AmlodipineDrug
Also called Twynsta Tab.
PO, Once daily(QD), 8weeks
Temisartan+RosuvastatinDrug
Also called Micardis Tab.+Crestor Tab.
PO, Once daily(QD), 8weeks

Study groups in NCT03067688
Study group	Role	What they receive
"Combination drug:Temisartan+Amlodipine+Rosuvastatin"	Experimental	60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks. Receives: Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug)
Temisartan+Amlodipine	Active comparator	60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks. Receives: Drug: Temisartan+Amlodipine
Temisartan+Rosuvastatin	Active comparator	60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks. Receives: Drug: Temisartan+Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 201727 Mar 2018

First posted1 Mar 2017
Study start11 Apr 2017
Primary completion27 Mar 2018
Study completion27 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Yuhan CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03067688
Sponsor's protocol ID: YHP1604-301
Status last verified: Jan 2019
First submitted: 1 Feb 2017
Last updated: 16 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32937023

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03067688
Acronym / sponsor ID: YHP1604-301
Conditions: Hypertension, Hyperlipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Yuhan CorporationIndustry (pharma, biotech, devices)
Study start: 11 Apr 2017 (actual)
Primary completion: 27 Mar 2018 (actual)
Study completion: 27 Mar 2018 (actual)
First posted: 1 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
"Combination drug:Temisartan+Amlodipine+Rosuvastatin"	Experimental	Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug)60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.
Temisartan+Amlodipine	Active comparator	Drug: Temisartan+Amlodipine60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.
Temisartan+Rosuvastatin	Active comparator	Drug: Temisartan+Rosuvastatin60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Signed informed consent
Subjects with hypertension and hyperlipidemia

Key exclusion criteria (2 listed)

Patients with known or suspected secondary hypertension
Other exclusions applied

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Temisartan+Amlodipine+Rosuvastatin (Combination drug)Also: Twynsta Tab.+Crestor Tab.PO, Once daily(QD), 8weeks	Drug	"Combination drug:Temisartan+Amlodipine+Rosuvastatin"
Temisartan+AmlodipineAlso: Twynsta Tab.PO, Once daily(QD), 8weeks	Drug	Temisartan+Amlodipine
Temisartan+RosuvastatinAlso: Micardis Tab.+Crestor Tab.PO, Once daily(QD), 8weeks	Drug	Temisartan+Rosuvastatin

Primary outcome

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

8 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Derived from this study: PubMed 32937023Jin 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.
Individual participant dataSharing planned: No

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hyunhee Na, MD study director

Yuhan Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean sitting systolic blood pressure (MSSBP) (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067688, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.