Healthy Normotensive ParticipantsPKLHNCT01858623
Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide
A study testing Losartan/hydrochlorothiazide, Losartan and Hydrochlorothiazide in people with Healthy Normotensive Participants, run by Damanhour University.
Trial summary
This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Normotensive Participants
- What is being tested?
- Losartan/hydrochlorothiazide, Losartan and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Mar 2013
- Phase
- Interventional
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 18 years old and not more than 45 healthy male volunteers
- Who had passed all the screening parameters
Who cannot join
- A clinically significant abnormal physical exam, medical history, or laboratory studies
- If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening
- The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
- A history of blood dyscrasias
- A history of alcohol or drug abuse within the past year
- Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
- Unable to tolerate vein puncture and multiple blood samplings
- Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
About this study
This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.
- Conditions
- Healthy Normotensive Participants
- Being tested
- Losartan/hydrochlorothiazide, Losartan, Hydrochlorothiazide
- Keywords
- Healthy Normotensive Participants, Fixed dose combination, Pharmacokinetics, Losartan, Hydrochlorothiazide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan/hydrochlorothiazideDrug
LosartanDrug
HydrochlorothiazideDrug
| Study group | Role | What they receive |
|---|---|---|
| Losartan / Hydrochlorothiazide100 mg/25mg | Other | Losartan / Hydrochlorothiazide100 mg/25mg fixed dose combination Receives: Drug: Losartan/hydrochlorothiazide |
| Losartan 100 mg | Other | Losartan 100 mg alone Receives: Drug: Losartan |
| hydrochlorothiazide 25 mg | Other | hydrochlorothiazide 25 mg alone Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: Participants will be followed for the duration of study, an expected average of 5 weeks.
Blood pressure
Measured: Participants will be monitored for the duration of study, an expected average of 5 weeks.
Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide
Measured: At the end of the study, after collection of all blood samples, an expected average of 4 weeks
Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide
Measured: At the end of the study, after collection of all blood samples, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Normotensive ParticipantsStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Helmy, PhD, CPHQ, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858623
- Sponsor's protocol ID
- PPT5
- Acronym
- PKLH
- Status last verified
- May 2013
- First submitted
- 12 May 2013
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide
- ClinicalTrials.gov ID
- NCT01858623
- Acronym / sponsor ID
- PKLH / PPT5
- Conditions
- Healthy Normotensive Participants
- Keywords
- Healthy Normotensive Participants, Fixed dose combination, Pharmacokinetics, Losartan, Hydrochlorothiazide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 May 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.
This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Losartan / Hydrochlorothiazide100 mg/25mg | Other | Drug: Losartan/hydrochlorothiazideLosartan / Hydrochlorothiazide100 mg/25mg fixed dose combination |
| Losartan 100 mg | Other | Drug: LosartanLosartan 100 mg alone |
| hydrochlorothiazide 25 mg | Other | Drug: Hydrochlorothiazidehydrochlorothiazide 25 mg alone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At least 18 years old and not more than 45 healthy male volunteers
- Who had passed all the screening parameters
Key exclusion criteria (8 listed)
- A clinically significant abnormal physical exam, medical history, or laboratory studies
- If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening
- The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
- A history of blood dyscrasias
- A history of alcohol or drug abuse within the past year
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 |
|---|---|---|
| Losartan/hydrochlorothiazide | Drug | Losartan / Hydrochlorothiazide100 mg/25mg |
| Losartan | Drug | Losartan 100 mg |
| Hydrochlorothiazide | Drug | hydrochlorothiazide 25 mg |
Primary outcome
Heart rate
Time frame: Participants will be followed for the duration of study, an expected average of 5 weeks.
Blood pressure
Time frame: Participants will be monitored for the duration of study, an expected average of 5 weeks.
Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide
Time frame: At the end of the study, after collection of all blood samples, an expected average of 4 weeks
Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide
Time frame: At the end of the study, after collection of all blood samples, an expected average of 4 weeks
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 27 May 2013.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Losartan/hydrochlorothiazide, Losartan and Hydrochlorothiazide in people with Healthy Normotensive Participants, run by Damanhour University.
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 2 inclusion and 8 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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Heart rate (time frame: Participants will be followed for the duration of study, an expected average of 5 weeks.). The study lists 4 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 27 May 2013.