HealthyNCT01858610
Drug Interaction Between Irbesartan and Hydrochlorothiazide
A study testing Irbeasartan/hydrochlorothiazide, Irbesartan and Hydrochlorothiazide in people with Healthy, run by Damanhour University at 1 site in Egypt.
Trial summary
This study was conducted to investigate any potential reaction between irbesartan 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
- What is being tested?
- Irbeasartan/hydrochlorothiazide, Irbesartan and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Apr 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 normotensive 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
Damanhur
About this study
This study was conducted to investigate any potential reaction between irbesartan and hydrochlorothiazide.
- Conditions
- Healthy
- Being tested
- Irbeasartan/hydrochlorothiazide, Irbesartan, Hydrochlorothiazide
- Keywords
- Fixed dose combination, Pharmacokinetics, Irbesartan, Hydrochlorothiazide, Pharmacodynamics, Normotensive Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbeasartan/hydrochlorothiazideDrug
Also called Fixed dose combination
IrbesartanDrug
HydrochlorothiazideDrug
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan alone | Other | Irbesartan 300 mg alone Receives: Drug: Irbesartan |
| Hydrochlorothiazide 25 mg alone | Other | Hydrochlorothiazide 25 mg alone Receives: Drug: Hydrochlorothiazide |
| Irbesartan 300 mg + Hydrochlorothiazide 25 mg | Other | Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination Receives: Drug: Irbeasartan/hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (systolic/diastolic)
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
pharmacokinetic parameter such as the Cmax of irbesartan and hydrochlorothiazide
Measured: After collection of all blood samples, an expected average of 4 weeks
Heart rate
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
pharmacokinetic parameter such as the AUC of irbesartan and hydrochlorothiazide
Measured: 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 startMar 2013
- Primary completionApr 2013
- Study completionApr 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 HealthyStudies 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
- NCT01858610
- Sponsor's protocol ID
- PPT4
- Status last verified
- May 2013
- First submitted
- 12 May 2013
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hedaya MA, Helmy SA. Modeling of the pharmacokinetic/pharmacodynamic interaction between irbesartan and hydrochlorothiazide in normotensive subjects. Biopharm Drug Dispos. 2015 May;36(4):216-31. doi: 10.1002/bdd.1935. Epub 2015 Feb 4.
PubMed 25545238
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
- Drug Interaction Between Irbesartan and Hydrochlorothiazide
- ClinicalTrials.gov ID
- NCT01858610
- Acronym / sponsor ID
- PPT4
- Conditions
- Healthy
- Keywords
- Fixed dose combination, Pharmacokinetics, Irbesartan, Hydrochlorothiazide, Pharmacodynamics, Normotensive Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 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 irbesartan and hydrochlorothiazide.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Irbesartan alone | Other | Drug: IrbesartanIrbesartan 300 mg alone |
| Hydrochlorothiazide 25 mg alone | Other | Drug: HydrochlorothiazideHydrochlorothiazide 25 mg alone |
| Irbesartan 300 mg + Hydrochlorothiazide 25 mg | Other | Drug: Irbeasartan/hydrochlorothiazideIrbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least 18 years old and not more than 45 healthy normotensive male volunteers Who had passed all the screening parameters
Key exclusion criteria (1 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 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
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 |
|---|---|---|
| Irbeasartan/hydrochlorothiazideAlso: Fixed dose combination | Drug | Irbesartan 300 mg + Hydrochlorothiazide 25 mg |
| Irbesartan | Drug | Irbesartan alone |
| Hydrochlorothiazide | Drug | Hydrochlorothiazide 25 mg alone |
Primary outcome
Blood pressure (systolic/diastolic)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
pharmacokinetic parameter such as the Cmax of irbesartan and hydrochlorothiazide
Time frame: After collection of all blood samples, an expected average of 4 weeks
Heart rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
pharmacokinetic parameter such as the AUC of irbesartan and hydrochlorothiazide
Time frame: 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.
- Derived from this study: PubMed 25545238Hedaya MA, Helmy SA. Modeling of the pharmacokinetic/pharmacodynamic interaction between irbesartan and hydrochlorothiazide in normotensive subjects. Biopharm Drug Dispos. 2015 May;36(4):216-31. doi: 10.1002/bdd.1935. Epub 2015 Feb 4.
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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 study testing Irbeasartan/hydrochlorothiazide, Irbesartan and Hydrochlorothiazide in people with Healthy, run by Damanhour University at 1 site in Egypt.
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 1 inclusion and 1 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.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
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?
Blood pressure (systolic/diastolic) (time frame: participants will be followed for the duration of hospital stay, 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?
On the ClinicalTrials.gov record for NCT01858610, 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 27 May 2013.