HypertensionPhase 1NCT02152969
Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)
A Phase 1 study testing Telmisartan, Amlodipine and Chlorthalidone in people with Hypertension, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
To evaluate Drug-drug interaction Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan, Amlodipine and Chlorthalidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Nov 2014
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight)
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Who cannot join
- History of and clinically significant disease psychiatric, or malignancy.
- 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.
- Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul
About this study
Official title: An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers
To evaluate Drug-drug interaction
Read the detailed description
The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.
- Conditions
- Hypertension
- Being tested
- Telmisartan, Amlodipine, Chlorthalidone
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
AmlodipineDrug
ChlorthalidoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Part B | Other | Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan. Receives: Drug: Telmisartan; Drug: Amlodipine; Drug: Chlorthalidone |
| Part A | Other | Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone. Receives: Drug: Telmisartan; Drug: Amlodipine; Drug: Chlorthalidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone
Measured: Totally 28points for 24 hours
Secondary outcomes (1)
Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone
Measured: Totally 28points for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionNov 2014
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Seok Yim, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152969
- Sponsor's protocol ID
- YH22162-101
- Status last verified
- Nov 2014
- First submitted
- 29 May 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02152969
- Acronym / sponsor ID
- YH22162-101
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Jun 2014 (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.
To evaluate Drug-drug interaction
Detailed description
The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part B | Other | Drug: Telmisartan, Drug: Amlodipine, Drug: ChlorthalidoneArm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan. |
| Part A | Other | Drug: Telmisartan, Drug: Amlodipine, Drug: ChlorthalidoneArm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight)
- 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 psychiatric, or malignancy.
- 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.
- Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
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 |
|---|---|---|
| Telmisartan | Drug | Part A, Part B |
| Amlodipine | Drug | Part A, Part B |
| Chlorthalidone | Drug | Part A, Part B |
Primary outcome
AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone
Time frame: Totally 28points for 24 hours
1 secondary outcome
Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone
Time frame: Totally 28points for 24 hours
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 19 Nov 2014.
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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.
Dong Seok Yim principal investigator
The Catholic University of Korea
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 Telmisartan, Amlodipine and Chlorthalidone in people with Hypertension, 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: finished, as of the sponsor's last update on 19 Nov 2014. 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?
AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone (time frame: Totally 28points for 24 hours). 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 19 Nov 2014.