Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

NCT ID: NCT01822860

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chlorthalidone 12.5 mg

Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.

Group Type EXPERIMENTAL

Chlorthalidone 12.5 mg

Intervention Type DRUG

Hydrochlorothiazide 25 mg

Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide 25 mg

Intervention Type DRUG

Placebo

Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Chlorthalidone 12.5 mg

Intervention Type DRUG

Hydrochlorothiazide 25 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Aboeata, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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13-16628

Identifier Type: -

Identifier Source: org_study_id

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