HypertensionPhase 4NCT02100462
Chlorthalidone and HCTZ Impacts on Platelet Activation
A Phase 4 study testing Chlorthalidone 12.5 mg, Hydrochlorothiazide 25 mg and Aspirin 81 mg in people with Hypertension, run by Creighton University at 1 site in United States.
Trial summary
This will be a randomized, double-blinded, three-period crossover study of platelet activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Chlorthalidone 12.5 mg, Hydrochlorothiazide 25 mg and Aspirin 81 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2016
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women age 19 or older
- Not currently taking any routinely scheduled prescription or over the counter medications or herbal supplements
- No use of aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, dipyridamole, NSAID medications, or herbal supplements within the previous 7 days and able to refrain from use during the study period
- Systolic blood pressure > 110 mmHg and diastolic blood pressure > 60 mmHg
- Non-smoker
Who cannot join
- Previous adverse reaction or allergy to HCTZ, CTD, or ASA
- Severe sulfonamide hypersensitivity (anaphylaxis or Stevens-Johnson syndrome)
- Diagnosis of any chronic disease or condition
- History of gout or hyperuricemia
- History of pancreatitis
- History of systemic lupus erythematosus (SLE)
Show all 11Show fewer
- History of hypokalemia requiring treatment
- Pregnant or planning to become pregnant during the study period
- Breastfeeding
- History of hypotension
- History of gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Creighton University
Omaha, Nebraska, 68178
Sandy Byers, RN, 402-280-4961, sandrabyers@creighton.edu
Tammy L Burns, PharmD, BCPS
About this study
Official title: Evaluation of Platelet Effects of Chlorthalidone and Hydrochlorothiazide
This will be a randomized, double-blinded, three-period crossover study of platelet activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis is that CTD has different effects on platelet activation and aggregation than HCTZ.
- Conditions
- Hypertension
- Being tested
- Chlorthalidone 12.5 mg, Hydrochlorothiazide 25 mg, Aspirin 81 mg
- Keywords
- Hypertension, Platelet activation, Platelet aggregation, Chlorthalidone
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorthalidone 12.5 mgDrug
Hydrochlorothiazide 25 mgDrug
Aspirin 81 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Chlorthalidone 12.5 mg | Experimental | Chlorthalidone 12.5 mg by mouth once daily for 2 weeks Receives: Drug: Chlorthalidone 12.5 mg |
| Hydrochlorothiazide 25 mg | Experimental | Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks Receives: Drug: Hydrochlorothiazide 25 mg |
| Aspirin 81 mg | Active comparator | Aspirin 81 mg by mouth once daily for 2 weeks Receives: Drug: Aspirin 81 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean fluorescence intensity of PAC-1
The primary endpoint for this study will be the change in mean fluorescence intensity (MFI) of the platelet activation marker PAC-1 due to HCTZ, CTD, and aspirin.
Measured: 2 weeks
Secondary outcomes (2)
Change in CD62P expression
Change in platelet expression of CD62P (p-selectin) in response to CTD, HCTZ, and ASA.
Measured: 2 weeks
Change in platelet aggregation
Change in platelet aggregation measured by flow cytometry in response to CTD, HCTZ, and ASA
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Responsible party
- Sponsor
- Investigators
- Khalid Bashir, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100462
- Sponsor's protocol ID
- 13-16785
- Status last verified
- Dec 2015
- First submitted
- 27 Mar 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bashir K, Burns T, Pirruccello SJ, Aurit SJ, Hilleman DE. Comparative antiplatelet effects of chlorthalidone and hydrochlorothiazide. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1310-1315. doi: 10.1111/jch.14564. Epub 2022 Sep 6.
PubMed 36067089
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet Effects of Chlorthalidone and Hydrochlorothiazide
- ClinicalTrials.gov ID
- NCT02100462
- Acronym / sponsor ID
- 13-16785
- Conditions
- Hypertension
- Keywords
- Hypertension, Platelet activation, Platelet aggregation, Chlorthalidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Apr 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.
This will be a randomized, double-blinded, three-period crossover study of platelet activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis is that CTD has different effects on platelet activation and aggregation than HCTZ.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorthalidone 12.5 mg | Experimental | Drug: Chlorthalidone 12.5 mgChlorthalidone 12.5 mg by mouth once daily for 2 weeks |
| Hydrochlorothiazide 25 mg | Experimental | Drug: Hydrochlorothiazide 25 mgHydrochlorothiazide 25 mg by mouth once daily for 2 weeks |
| Aspirin 81 mg | Active comparator | Drug: Aspirin 81 mgAspirin 81 mg by mouth once daily for 2 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women age 19 or older
- Not currently taking any routinely scheduled prescription or over the counter medications or herbal supplements
- No use of aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, dipyridamole, NSAID medications, or herbal supplements within the previous 7 days and able to refrain from use during the study period
- Systolic blood pressure > 110 mmHg and diastolic blood pressure > 60 mmHg
- Non-smoker
Key exclusion criteria (11 listed)
- Previous adverse reaction or allergy to HCTZ, CTD, or ASA
- Severe sulfonamide hypersensitivity (anaphylaxis or Stevens-Johnson syndrome)
- Diagnosis of any chronic disease or condition
- History of gout or hyperuricemia
- History of pancreatitis
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 |
|---|---|---|
| Chlorthalidone 12.5 mg | Drug | Chlorthalidone 12.5 mg |
| Hydrochlorothiazide 25 mg | Drug | Hydrochlorothiazide 25 mg |
| Aspirin 81 mg | Drug | Aspirin 81 mg |
Primary outcome
Change in mean fluorescence intensity of PAC-1
Time frame: 2 weeks
The primary endpoint for this study will be the change in mean fluorescence intensity (MFI) of the platelet activation marker PAC-1 due to HCTZ, CTD, and aspirin.
2 secondary outcomes
Change in CD62P expression
Time frame: 2 weeks
Change in platelet aggregation
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Derived from this study: PubMed 36067089Bashir K, Burns T, Pirruccello SJ, Aurit SJ, Hilleman DE. Comparative antiplatelet effects of chlorthalidone and hydrochlorothiazide. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1310-1315. doi: 10.1111/jch.14564. Epub 2022 Sep 6.
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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.
Khalid Bashir, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorthalidone 12.5 mg, Hydrochlorothiazide 25 mg and Aspirin 81 mg in people with Hypertension, run by Creighton University at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 14 Dec 2015. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandy Byers, RN (402-280-4961, sandrabyers@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean fluorescence intensity of PAC-1 (time frame: 2 weeks). 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 NCT02100462, 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 14 Dec 2015.