Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

NCT01822860 | Withdrawn Phase 4 DMC

• 1 other identifier: 13-16628
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

Hypertension; Endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

• Flow mediated vasodilatation

  Flow mediated vasodilatation will be measured after one month on each drug and placebo

  4 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Chlorthalidone 12.5 mg

EXPERIMENTAL

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

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.

Drug: Hydrochlorothiazide 25 mg

Interventions

Chlorthalidone 12.5 mg DRUG

Chlorthalidone 12.5 mg

Hydrochlorothiazide 25 mg DRUG

Hydrochlorothiazide 25 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Chlorthalidone; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Thiazides

Study Officials

• Ahmed Aboeata, MBBCh

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 2, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

US (1)