Essential HypertensionPhase 1NCT01198249
Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension
A Phase 1 study testing multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide in people with Essential Hypertension, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Mar 2011
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult subjects 20-50 years of age
- Above 55Kg and within ±20% ideal body weight
- Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) < 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) < 100mmHg
- Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
- Subjects who wrote informed consent
Who cannot join
- Subjects who are suspected to have acute disease
- Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
- Subjects who have gastrointestinal history
- Subjects whose heartrate is less than 60
- Subject who suspected to orthostatic hypotension
- Subjects who have clinically significant allergy disease
Show all 11Show fewer
- Subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
- Administration of prescription drug within 14 days or over the counter (OTC) drug within 7 days
- Subjects who have past history of drug abuse and positive in drug screening test
- Subjects who donate whole blood within 60 days and platelet within 30days.
- Subjects taking St John's wort or CYP inhibitor and inducer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Multiple Dose, Crossover Study to Investigate Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide(HCTZ) in Subjects With (Pre)Hypertension
This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug.
- Conditions
- Essential Hypertension
- Being tested
- multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazideDrug
amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study
| Study group | Role | What they receive |
|---|---|---|
| amlodipine monotherapy | Experimental | Not described Receives: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide |
| losartan monotherapy | Experimental | Not described Receives: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide |
| HCTZ | Experimental | Not described Receives: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide |
| mlodipine and Losartan and HCTZ | Experimental | Not described Receives: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Jae-Yong Chung, MD, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198249
- Sponsor's protocol ID
- 4-2010-0295
- Status last verified
- Mar 2011
- First submitted
- 8 Sep 2010
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. 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 Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide(HCTZ) in Subjects With (Pre)Hypertension
- ClinicalTrials.gov ID
- NCT01198249
- Acronym / sponsor ID
- 4-2010-0295
- Conditions
- Essential Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Sep 2010 (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 study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| amlodipine monotherapy | Experimental | Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide |
| losartan monotherapy | Experimental | Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide |
| HCTZ | Experimental | Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide |
| mlodipine and Losartan and HCTZ | Experimental | Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult subjects 20-50 years of age
- Above 55Kg and within ±20% ideal body weight
- Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) < 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) < 100mmHg
- Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
- Subjects who wrote informed consent
Key exclusion criteria (11 listed)
- Subjects who are suspected to have acute disease
- Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
- Subjects who have gastrointestinal history
- Subjects whose heartrate is less than 60
- Subject who suspected to orthostatic hypotension
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 |
|---|---|---|
| multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazideamlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study | Drug | HCTZ, amlodipine monotherapy, losartan monotherapy, mlodipine and Losartan and HCTZ |
Primary outcome
Not reported in the source record.
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 28 Mar 2011.
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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.
Jae-Yong Chung, MD, Ph.D principal investigator
Severance Hospital
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 multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide in people with Essential Hypertension, run by Yonsei University 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 5 inclusion and 11 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 28 Mar 2011. 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.
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 28 Mar 2011.