Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

March 24, 2015 updated by: Creighton University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow mediated vasodilatation
Time Frame: 4 weeks
Flow mediated vasodilatation will be measured after one month on each drug and placebo
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: Ahmed Aboeata, MBBCh, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (ESTIMATE)

April 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-16628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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