HypertensionPhase 4NCT01822860
Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function
A Phase 4 study testing Chlorthalidone 12.5 mg and Hydrochlorothiazide 25 mg in people with Hypertension, run by Creighton University at 1 site in United States.
Trial summary
Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Chlorthalidone 12.5 mg and Hydrochlorothiazide 25 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 or older
- Diagnosis of hypertension
- Current blood pressure > 120/80 mm Hg
Who cannot join
- Use of a thiazide-type diuretic within the last 1 month
- Known allergy to any study medications
- History of gout or hyperuricemia
- SCr >/= 1.8 mg/dl or CrCl < 25 ml/min
- Pregnancy or breastfeeding or planning to become pregnant during study period
- Dementia or cognitive impairment
Show all 9Show fewer
- Hypokalemia
- Acute coronary syndrome or stroke within 6 months
- Current use of sildenafil, tadalafil, or vardenafil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function in Hypertensive Patients: A Pilot Study
Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation.
Read the detailed description
This is a randomized, double-blind, crossover study to evaluate chlorthalidone and hydrochlorothiazide and their effects on endothelial function in hypertensive patients. Subjects will receive chlorthalidone 12.5 mg, hydrochlorothiazide 25 mg, and placebo each for 4 weeks with a 1 week washout between study periods. Sequence of study drugs will be randomized. Flow mediated vasodilatation will be measured at baseline and after each treatment period.
- Conditions
- Hypertension
- Being tested
- Chlorthalidone 12.5 mg, Hydrochlorothiazide 25 mg, Placebo
- Keywords
- Hypertension, Endothelial dysfunction
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. Receives: Drug: Placebo |
| Chlorthalidone 12.5 mg | Experimental | Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. Receives: Drug: Chlorthalidone 12.5 mg |
| Hydrochlorothiazide 25 mg | Active comparator | Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. Receives: Drug: Hydrochlorothiazide 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated vasodilatation
Flow mediated vasodilatation will be measured after one month on each drug and placebo
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Study subjects were not able to be recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Aboeata, MBBCh, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822860
- Sponsor's protocol ID
- 13-16628
- Status last verified
- Mar 2015
- First submitted
- 28 Mar 2013
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function in Hypertensive Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT01822860
- Acronym / sponsor ID
- 13-16628
- Conditions
- Hypertension
- Keywords
- Hypertension, Endothelial dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study subjects were not able to be recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Apr 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.
Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation.
Detailed description
This is a randomized, double-blind, crossover study to evaluate chlorthalidone and hydrochlorothiazide and their effects on endothelial function in hypertensive patients. Subjects will receive chlorthalidone 12.5 mg, hydrochlorothiazide 25 mg, and placebo each for 4 weeks with a 1 week washout between study periods. Sequence of study drugs will be randomized. Flow mediated vasodilatation will be measured at baseline and after each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. |
| Chlorthalidone 12.5 mg | Experimental | Drug: Chlorthalidone 12.5 mgSubjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. |
| Hydrochlorothiazide 25 mg | Active comparator | Drug: Hydrochlorothiazide 25 mgSubjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 19 or older
- Diagnosis of hypertension
- Current blood pressure > 120/80 mm Hg
Key exclusion criteria (9 listed)
- Use of a thiazide-type diuretic within the last 1 month
- Known allergy to any study medications
- History of gout or hyperuricemia
- SCr >/= 1.8 mg/dl or CrCl < 25 ml/min
- Pregnancy or breastfeeding or planning to become pregnant during study period
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 |
| Placebo | Drug | Placebo |
Primary outcome
Flow mediated vasodilatation
Time frame: 4 weeks
Flow mediated vasodilatation will be measured after one month on each drug and placebo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
Ahmed Aboeata, MBBCh 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 and Hydrochlorothiazide 25 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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 25 Mar 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Flow mediated vasodilatation (time frame: 4 weeks). 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 25 Mar 2015.