HypertensionPhase 1NCT01806363
Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone
A Phase 1 study testing Telmisartan 80mg and Chlorthalidone 25mg in people with Hypertension, run by HanAll BioPharma Co., Ltd. at 1 site in South Korea.
Trial summary
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan 80mg and Chlorthalidone 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Jun 2013
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Age(yr)between 20 and 50
- Signed written informed consent
Who cannot join
- Known hypersensitivity to investigator product, thiazide, sulphonamide and other drugs or additive.
- History of any siginificant Sickness, Cardiovascular, Respiratory, Renal, Endocrine, Neurological, Psychic, Cancer, Gasstrointestinal, Hematologic.
- History of drug and/or alcohol abuse
- Over 10 tobaccos a day
- Other condition which in the opinion of the investigator preclude enrollment into the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook national university hospital Clionical center
Daegu, Gyeongsangbuk-do, 700-721
About this study
Official title: A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.
- Conditions
- Hypertension
- Being tested
- Telmisartan 80mg, Chlorthalidone 25mg
- Keywords
- Pharmacokinetics, Safety, Male
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan 80mgDrug
Chlorthalidone 25mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A: Telmisartan, Chlorthalidone + Telmisartan | Active comparator | telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally Receives: Drug: Telmisartan 80mg; Drug: Chlorthalidone 25mg |
| Part B: Chlorthalidone, Chlorthalidone + Telmisartan | Active comparator | telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally Receives: Drug: Telmisartan 80mg; Drug: Chlorthalidone 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A : AUC, Cmax of Telmisartan
Measured: Over a 24-hour sampling period
Part B : AUC, Cmax of Chlorthalidone
Measured: Over a 24-hour sampling period
Secondary outcomes (2)
Part A : Cmin, tmax, CL/F of Telmisartan
Measured: Over a 24-hour sampling period
Part B : Cmin, tmax, CL/F of Chlorthalidone
Measured: Over a 24-hour sampling period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Ran Yoon, Associate Professor, Principal investigator, KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806363
- Sponsor's protocol ID
- HTECHL12I_1
- Status last verified
- Feb 2014
- First submitted
- 4 Mar 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seong SJ, Lim MS, Lee J, Ohk B, Gwon MR, Kim BK, Kim HJ, Yang DH, Lee HW, Kang WY, Yoon YR. Evaluation of a Pharmacokinetic Interaction between Telmisartan and Chlorthalidone in Healthy Male Adult Subjects. Clin Drug Investig. 2016 Aug;36(8):613-23. doi: 10.1007/s40261-016-0406-y.
PubMed 27206575
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT01806363
- Acronym / sponsor ID
- HTECHL12I_1
- Conditions
- Hypertension
- Keywords
- Pharmacokinetics, Safety, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Mar 2013 (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.
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Telmisartan, Chlorthalidone + Telmisartan | Active comparator | Drug: Telmisartan 80mg, Drug: Chlorthalidone 25mgtelmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally |
| Part B: Chlorthalidone, Chlorthalidone + Telmisartan | Active comparator | Drug: Telmisartan 80mg, Drug: Chlorthalidone 25mgtelmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects
- Age(yr)between 20 and 50
- Signed written informed consent
Key exclusion criteria (5 listed)
- Known hypersensitivity to investigator product, thiazide, sulphonamide and other drugs or additive.
- History of any siginificant Sickness, Cardiovascular, Respiratory, Renal, Endocrine, Neurological, Psychic, Cancer, Gasstrointestinal, Hematologic.
- History of drug and/or alcohol abuse
- Over 10 tobaccos a day
- Other condition which in the opinion of the investigator preclude enrollment into the study
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 80mg | Drug | Part A: Telmisartan, Chlorthalidone + Telmisartan, Part B: Chlorthalidone, Chlorthalidone + Telmisartan |
| Chlorthalidone 25mg | Drug | Part A: Telmisartan, Chlorthalidone + Telmisartan, Part B: Chlorthalidone, Chlorthalidone + Telmisartan |
Primary outcome
Part A : AUC, Cmax of Telmisartan
Time frame: Over a 24-hour sampling period
Part B : AUC, Cmax of Chlorthalidone
Time frame: Over a 24-hour sampling period
2 secondary outcomes
Part A : Cmin, tmax, CL/F of Telmisartan
Time frame: Over a 24-hour sampling period
Part B : Cmin, tmax, CL/F of Chlorthalidone
Time frame: Over a 24-hour sampling period
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 25 Feb 2014.
- Derived from this study: PubMed 27206575Seong SJ, Lim MS, Lee J, Ohk B, Gwon MR, Kim BK, Kim HJ, Yang DH, Lee HW, Kang WY, Yoon YR. Evaluation of a Pharmacokinetic Interaction between Telmisartan and Chlorthalidone in Healthy Male Adult Subjects. Clin Drug Investig. 2016 Aug;36(8):613-23. doi: 10.1007/s40261-016-0406-y.
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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.
Young Ran Yoon, Associate Professor principal investigator
KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER
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 80mg and Chlorthalidone 25mg in people with Hypertension, run by HanAll BioPharma Co., Ltd. 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 25 Feb 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?
Part A : AUC, Cmax of Telmisartan (time frame: Over a 24-hour sampling period). 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 NCT01806363, 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 25 Feb 2014.