NCT01748123

Brief Summary

  • Clinical equipoise exists with respect to the important question, "What is the best initial diuretic for the treatment of Hypertension"? A pragmatic comparative effectiveness research (CER) study comparing Chlorthalidone to Hydrochlorthiazide (HCTZ) could help inform decision making for this common problem.
  • The investigators aim to harness both the power of bioinformatics (using web-based data-capture and electronic health records) and of online media (through collaboration) in order to facilitate such a CER in "usual-care" settings. This process may also provide a foundation for testing a wealth of important clinical questions which commonly arise in the delivery of contemporary healthcare and would otherwise be left unanswered.
  • To this end the investigators are developing a website, EBMtrialcentral, where eligible physicians can go online and join their collaborative network. Physicians can then enroll eligible patients in this study. These will include under-served urban patients. Clinical information will be entered online (using a secure database housed at Johns Hopkins), patient consent will be obtained electronically and treatment recommendations will be randomly allocated to either 25mg daily of oral HCTZ or 12.5mg daily of oral Chlorthalidone. The investigators aim to increase to 50mg HCTZ and 25mg Chlorthalidone over 8 weeks and compare their effects on BP measured with a 24 hour monitor.
  • The investigators' primary hypothesis is that non-blinded, random, parallel allocation of 12.5mg daily Chlorthalidone (titrated to 25mg at 4 weeks) will demonstrate a clinically meaningful ≥5mmHg improvement in BP control (as measured by change in BP from baseline using 24hr ABPM) compared to 25mg daily HCTZ (titrated to 50mg at 4 weeks) in newly hypertensive patients followed in a usual-care clinic setting over 8 weeks. They will also analyze differences in side-effects or safety (serum electrolytes) between these two medications.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
3.6 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

December 10, 2012

Last Update Submit

August 15, 2017

Conditions

Hypertension

Keywords

PragmaticComparative Effectiveness

Outcome Measures

Primary Outcomes (1)

  • Mean systolic 24 Hour Ambulatory Blood Pressure

    8 weeks

Secondary Outcomes (1)

  • Subjective Medication Side Effects

    4 and 8 weeks

Other Outcomes (3)

  • Serum Potassium

    4 and 8 weeks

  • Serum Magnesium

    4 and 8 weeks

  • Office Systolic BP assessment

    4 and 8 weeks

Study Arms (2)

Chlorthalidone

ACTIVE COMPARATOR

25mg daily orally for 8 weeks

Drug: Chlorthalidone

Hydrochlorothiazide

ACTIVE COMPARATOR

50mg daily orally for 8 weeks

Drug: Hydrochlorothiazide

Interventions

ChlorthalidoneDRUG

Initial dose of 12.5mg daily Chlorthalidone (force titrated to 25mg at 4 weeks)

Also known as: Hygroton, Tenoretic
Chlorthalidone
HydrochlorothiazideDRUG

Initial dose 25mg daily HCTZ (force titrated to 50mg at 4 weeks)

Also known as: Apo-hydro, Aquazide h, Dichlotride, Oretic
Hydrochlorothiazide

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women are eligible if they have hypertension, are not receiving antihypertensive medications, and have average office BP values within the last 6 months ≥140/90 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Chlorthalidoneatenolol, chlortalidone drug combinationsHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesThiazides

Study Officials

  • Steven P Schulman, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

US(1)