HypertensionPhase 1NCT02608242
PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin
A Phase 1 study testing YH22189, Twynsta 80/10mg and Crestor 20mg in people with Hypertension and Hyperlipidemia, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- YH22189, Twynsta 80/10mg and Crestor 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Jun 2016
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Who cannot join
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
- Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.
Read the detailed description
This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22189 FDC or telmisartan/amlodipine or rosuvastatin administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The three treatment periods will be separated by a washout period.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- YH22189, Twynsta 80/10mg, Crestor 20mg
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH22189Drug
Twynsta 80/10mgDrug
Also called Telmisartan/Amlodipine 80/10mg(FDC)
Crestor 20mgDrug
Also called Rosuvastatin 20mg
| Study group | Role | What they receive |
|---|---|---|
| YH22189 | Experimental | YH22189 FDC tablet of Yuhan Corporation Receives: Drug: YH22189 |
| Twynsta 80/10mg | Active comparator | Telmisartan/Amlodipine 80/10mg (FDC) Receives: Drug: Twynsta 80/10mg |
| Crestor 20mg | Active comparator | Rosuvastatin 20mg Receives: Drug: Crestor 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telmisartan Cmax
Measured: 0 - 72 hrs
Telmisartan AUClast
Measured: 0 - 72 hrs
Amlodipine Cmax
Measured: 0 - 168 hrs
Amlodipine AUClast
Measured: 0 - 168 hrs
Rosuvastatin Cmax
Measured: 0 - 48 hrs
Rosuvastatin AUClast
Measured: 0 - 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: sponsor decision
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608242
- Sponsor's protocol ID
- YH22189-102
- Status last verified
- Jan 2017
- First submitted
- 11 Nov 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02608242
- Acronym / sponsor ID
- YH22189-102
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Nov 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.
This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.
Detailed description
This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22189 FDC or telmisartan/amlodipine or rosuvastatin administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The three treatment periods will be separated by a washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YH22189 | Experimental | Drug: YH22189YH22189 FDC tablet of Yuhan Corporation |
| Twynsta 80/10mg | Active comparator | Drug: Twynsta 80/10mgTelmisartan/Amlodipine 80/10mg (FDC) |
| Crestor 20mg | Active comparator | Drug: Crestor 20mgRosuvastatin 20mg |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Key exclusion criteria (5 listed)
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
- Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)
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 |
|---|---|---|
| YH22189 | Drug | YH22189 |
| Twynsta 80/10mgAlso: Telmisartan/Amlodipine 80/10mg(FDC) | Drug | Twynsta 80/10mg |
| Crestor 20mgAlso: Rosuvastatin 20mg | Drug | Crestor 20mg |
Primary outcome
Telmisartan Cmax
Time frame: 0 - 72 hrs
Telmisartan AUClast
Time frame: 0 - 72 hrs
Amlodipine Cmax
Time frame: 0 - 168 hrs
Amlodipine AUClast
Time frame: 0 - 168 hrs
Rosuvastatin Cmax
Time frame: 0 - 48 hrs
Rosuvastatin AUClast
Time frame: 0 - 48 hrs
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YH22189, Twynsta 80/10mg and Crestor 20mg in people with Hypertension and Hyperlipidemia, run by Yuhan Corporation at 1 site in South Korea.
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 5 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: stopped early, as of the sponsor's last update on 1 Feb 2017. 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 was stopped early (reason given: sponsor decision). Results are not available in the source record.
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?
Telmisartan Cmax (time frame: 0 - 72 hrs). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2017.