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Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

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ClinicalTrials.gov Identifier: NCT01822860
Recruitment Status : Withdrawn (Study subjects were not able to be recruited)
First Posted : April 2, 2013
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Creighton University

Brief Summary:
Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Chlorthalidone 12.5 mg Drug: Hydrochlorothiazide 25 mg Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function in Hypertensive Patients: A Pilot Study
Study Start Date : March 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.
Drug: Placebo
Experimental: Chlorthalidone 12.5 mg
Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.
Drug: Chlorthalidone 12.5 mg
Active Comparator: Hydrochlorothiazide 25 mg
Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.
Drug: Hydrochlorothiazide 25 mg



Primary Outcome Measures :
  1. Flow mediated vasodilatation [ Time Frame: 4 weeks ]
    Flow mediated vasodilatation will be measured after one month on each drug and placebo



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 19 or older
  • Diagnosis of hypertension
  • Current blood pressure > 120/80 mm Hg

Exclusion Criteria:

  • 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
  • Hypokalemia
  • Acute coronary syndrome or stroke within 6 months
  • Current use of sildenafil, tadalafil, or vardenafil

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822860


Locations
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United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
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Principal Investigator: Ahmed Aboeata, MBBCh Creighton University

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Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01822860     History of Changes
Other Study ID Numbers: 13-16628
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Creighton University:
Hypertension
Endothelial dysfunction
Additional relevant MeSH terms:
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Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chlorthalidone
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action