HypertensionPhase 1NCT02387619

The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

A Phase 1 study testing Rosuvastatin, Telmisartan/Amlodipine and Rosuvastatin and Telmisartan/Amlodipine in people with Hypertension and Hyperlipidemia, run by Jeil Pharmaceutical Co., Ltd. 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

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers Read more about this study

Who is it for?: Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension, Hyperlipidemia
What is being tested?: Rosuvastatin, Telmisartan/Amlodipine and Rosuvastatin and Telmisartan/Amlodipine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteSouth Korea
Study dates: Feb 2015to Jul 2015
Phase: Phase 1
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 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

19~55 years healthy male
Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
Subjects who agree to keep contraceptive methods during the clinical trial.

Who cannot join

Subjects who are allergic to investigational drug.
Subjects who have a medical history which can affect the clinical trial.
Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Yonsei University Health System
Seoul, Seodaemun-gu, 120-752

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Read the detailed description

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Conditions: Hypertension, Hyperlipidemia
Being tested: Rosuvastatin, Telmisartan/Amlodipine, Rosuvastatin and Telmisartan/Amlodipine
Medical subject headings: Hypertension, Hyperlipidemias

What participants receive

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

RosuvastatinDrug
Also called Crestor
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
Telmisartan/AmlodipineDrug
Also called Twynsta
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
Rosuvastatin and Telmisartan/AmlodipineDrug
Also called Crestor and Twynsta
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days

Study groups in NCT02387619
Study group	Role	What they receive
Group 1 of part 1	Experimental	Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2 Receives: Drug: Rosuvastatin; Drug: Rosuvastatin and Telmisartan/Amlodipine
Group 2 of part 1	Experimental	Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2 Receives: Drug: Telmisartan/Amlodipine; Drug: Rosuvastatin and Telmisartan/Amlodipine
Group 1 of part 2	Experimental	Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2 Receives: Drug: Rosuvastatin; Drug: Rosuvastatin and Telmisartan/Amlodipine
Group 2 of part 2	Experimental	Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2 Receives: Drug: Telmisartan/Amlodipine; Drug: Rosuvastatin and Telmisartan/Amlodipine

What is being measured

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

AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
Measured: 72hours, 144hours

Secondary outcomes (8)

AUClast,ss of Rosuvastatin
Measured: 72hours
AUCinf,ss of Rosuvastatin
Measured: 72hours
Tmax,ss of Rosuvastatin
Measured: 72hours
t1/2 of Rosuvastatin
Measured: 72hours
AUClast,ss of Telmisartan, Amlodipine
Measured: 144hours
AUCinf,ss of Telmisartan, Amlodipine
Measured: 144hours
Tmax,ss of Telmisartan, Amlodipine
Measured: 144hours
t1/2 of Telmisartan, Amlodipine
Measured: 144hours

Timeline

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

Feb 2015Jul 2015

First posted13 Mar 2015 (estimated)
Study startFeb 2015
Primary completionMar 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02387619
Sponsor's protocol ID: JLP-1401-P1-DI
Status last verified: Mar 2015
First submitted: 9 Mar 2015
Last updated: 24 Jun 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02387619
Acronym / sponsor ID: JLP-1401-P1-DI
Conditions: Hypertension, Hyperlipidemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Mar 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 13 Mar 2015 (estimated)
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.

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Detailed description

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1 of part 1	Experimental	Drug: Rosuvastatin, Drug: Rosuvastatin and Telmisartan/AmlodipineRosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2
Group 2 of part 1	Experimental	Drug: Telmisartan/Amlodipine, Drug: Rosuvastatin and Telmisartan/AmlodipineRosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2
Group 1 of part 2	Experimental	Drug: Rosuvastatin, Drug: Rosuvastatin and Telmisartan/AmlodipineRosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2
Group 2 of part 2	Experimental	Drug: Telmisartan/Amlodipine, Drug: Rosuvastatin and Telmisartan/AmlodipineRosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2

Who may qualify

Ages: 19 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

19~55 years healthy male
Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
Subjects who agree to keep contraceptive methods during the clinical trial.

Key exclusion criteria (4 listed)

Subjects who are allergic to investigational drug.
Subjects who have a medical history which can affect the clinical trial.
Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

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
RosuvastatinAlso: CrestorRosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days	Drug	Group 1 of part 1, Group 1 of part 2
Telmisartan/AmlodipineAlso: TwynstaRosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days	Drug	Group 2 of part 1, Group 2 of part 2
Rosuvastatin and Telmisartan/AmlodipineAlso: Crestor and TwynstaRosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days	Drug	Group 1 of part 1, Group 1 of part 2, Group 2 of part 1, Group 2 of part 2

Primary outcome

AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
Time frame: 72hours, 144hours

8 secondary outcomes

AUClast,ss of Rosuvastatin
Time frame: 72hours
AUCinf,ss of Rosuvastatin
Time frame: 72hours
Tmax,ss of Rosuvastatin
Time frame: 72hours
t1/2 of Rosuvastatin
Time frame: 72hours
AUClast,ss of Telmisartan, Amlodipine
Time frame: 144hours
AUCinf,ss of Telmisartan, Amlodipine
Time frame: 144hours
Tmax,ss of Telmisartan, Amlodipine
Time frame: 144hours
t1/2 of Telmisartan, Amlodipine
Time frame: 144hours

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 24 Jun 2016.
Individual participant dataSharing planned: No

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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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
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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.

Kyungsoo Park, MD, Ph.D. principal investigator

Yonsei University

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 3 inclusion and 4 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 24 Jun 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine (time frame: 72hours, 144hours). 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 NCT02387619.

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 24 Jun 2016.