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HypertensionPhase 3DCPNCT02185417

Diuretic Comparison Project

A Phase 3 study testing Hydrochlorothiazide (HCTZ) and Chlorthalidone (CTD) in people with Hypertension, run by VA Office of Research and Development at 70 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The Diuretic Comparison Project aimed to evaluate whether chlorthalidone, as compared with hydrochlorothiazide, would reduce the risk of major nonfatal cardiovascular disease outcomes and non-cancer-related deaths in older patients with hypertension who were receiving hydrochlorothiazide at baseline. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hypertension
What is being tested?
Hydrochlorothiazide (HCTZ) and Chlorthalidone (CTD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20,723 participants
Where
70 sitesin 2 countries
Study dates
15 Jun 2016to 29 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • over age 65 years
  • receiving hydrochlorothiazide from the VA pharmacy at a daily dose of 25 or 50 mg
  • most recent SBP ≥120 mm Hg and no records of SBP <120 mm Hg in the past 90 days

Who cannot join

  • impaired decision-making capacity rendering the patient unable to provide informed consent (i.e., if there is any question during the nurse's EHR chart review that the individual does not have the ability to make an autonomous decision or the PCP declines permission to randomize)
  • death expected within 6 months (inferred by PCP permission to randomize)
  • blood potassium level <3.1 or 3.5 (if taking digoxin) meq/L in the past 90 days
  • blood sodium level <130 meq/L in the past 90 days
  • enrolled in Medicare Part C (This exclusion only applied if there might be insufficient EHR data available to the study team)

Trial locations and contacts

70 sites in 2 countries.

70 sites in 2 countries

United States69 sites

  • Albany VA Medical Center Samuel S. Stratton, Albany, NY

    Albany, New York, 12208

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico, 87108-5153

  • Alaska VA Healthcare System, Anchorage, AK

    Anchorage, Alaska, 99504

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045

  • Rehabilitation R&D Service, Baltimore, MD

    Baltimore, Maryland, 21202

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida, 33744

  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    Bedford, Massachusetts, 01730

  • VA Gulf Coast Veterans Health Care System, Biloxi, MS

    Biloxi, Mississippi, 39531

  • Birmingham VA Medical Center, Birmingham, AL

    Birmingham, Alabama, 35233

  • Boise VA Medical Center, Boise, ID

    Boise, Idaho, 83702

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5799

  • Cincinnati VA Medical Center, Cincinnati, OH

    Cincinnati, Ohio, 45220

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106

  • Coatesville VA Medical Center, Coatesville, PA

    Coatesville, Pennsylvania, 19320

  • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

    Columbia, South Carolina, 29209

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216

  • VA Illiana Health Care System, Danville, IL

    Danville, Illinois, 61832

  • Dayton VA Medical Center, Dayton, OH

    Dayton, Ohio, 45428

  • VA Central Iowa Health Care System, Des Moines, IA

    Des Moines, Iowa, 50310-5774

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705

  • Fargo VA Healthcare System, Fargo, ND

    Fargo, North Dakota, 58102

  • Veterans Health Care System of the Ozarks, Fayetteville, AR

    Fayetteville, Arkansas, 72703

  • VA Central California Health Care System, Fresno, CA

    Fresno, California, 93703

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608

  • Grand Junction VA Medical Center, Grand Junction, CO

    Grand Junction, Colorado, 81501

  • Hampton VA Medical Center, Hampton, VA

    Hampton, Virginia, 23667

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-5000

  • VA Pacific Islands Health Care System, Honolulu, HI

    Honolulu, Hawaii, 96819-1522

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030

  • Huntington VA Medical Center, Huntington, WV

    Huntington, West Virginia, 25704

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

  • Iowa City VA Health Care System, Iowa City, IA

    Iowa City, Iowa, 52246-2208

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128

  • Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

    Little Rock, Arkansas, 72205-5484

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    Madison, Wisconsin, 53705

  • Manchester VA Medical Center, Manchester, NH

    Manchester, New Hampshire, 03104

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee, 38104-2127

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee, 38104

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    Milwaukee, Wisconsin, 53295-1000

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417

  • Jackson C. Montgomery VA Medical Center, Muskogee, OK

    Muskogee, Oklahoma, 74401

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    Nashville, Tennessee, 37212-2637

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    New York, New York, 10010

  • Captain James A. Lovell Federal Health Care Center, North Chicago, IL

    North Chicago, Illinois, 60064

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    Omaha, Nebraska, 68105-1873

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1290

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97239

  • VA Roseburg Healthcare System, Roseburg, OR

    Roseburg, Oregon, 97471

  • Aleda E. Lutz VA Medical Center, Saginaw, MI

    Saginaw, Michigan, 48602

  • St. Cloud VA Health Care System, St. Cloud, MN

    Saint Cloud, Minnesota, 56303

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas, 78229

  • Sheridan VA Medical Center, Sheridan, WY

    Sheridan, Wyoming, 82801

  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO

    St Louis, Missouri, 63106

  • VA Black Hills Health Care System Fort Meade Campus, Fort Meade, SD

    Sturgis, South Dakota, 57741

  • Syracuse VA Medical Center, Syracuse, NY

    Syracuse, New York, 13210

  • Maine VA Medical Center, Augusta, ME

    Togus, Maine, 04330

  • Tomah VA Medical Center, Tomah, WI

    Tomah, Wisconsin, 54660

  • Washington DC VA Medical Center, Washington, DC

    Washington D.C., District of Columbia, 20422

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073

  • VA Southern Oregon Rehabilitation Center and Clinics, White City, OR

    White City, Oregon, 97503

  • White River Junction VA Medical Center, White River Junction, VT

    White River Junction, Vermont, 05009-0001

  • Wilkes-Barre VA Medical Center, Wilkes-Barre, PA

    Wilkes-Barre, Pennsylvania, 18711

  • Wilmington VA Medical Center, Wilmington, DE

    Wilmington, Delaware, 19805

Other trials in United States

Puerto Rico1 site

  • VA Caribbean Healthcare System, San Juan, PR

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: CSP #597 - Diuretic Comparison Project

The Diuretic Comparison Project aimed to evaluate whether chlorthalidone, as compared with hydrochlorothiazide, would reduce the risk of major nonfatal cardiovascular disease outcomes and non-cancer-related deaths in older patients with hypertension who were receiving hydrochlorothiazide at baseline. The investigators incorporated the pragmatic methods used by the Department of Veterans Affairs (VA) Healthcare System to provide a real-world assessment of the effectiveness of chlorthalidone as compared with hydrochlorothiazide in routine clinical care.

Read the detailed description

Thiazide-type diuretics have been in use for more than 50 years and are considered as the first-line treatment for hypertension. Of the more than 1 million Veterans prescribed a thiazide-type diuretic each year, more than 95% receive hydrochlorothiazide, and fewer than 2.5% receive chlorthalidone. However, indirect evidence has been accumulating for many years that chlorthalidone may be more effective than hydrochlorothiazide at preventing cardiovascular events.

The Diuretic Comparison Project was conducted with a clinically integrated design (termed a "point of care" or "pragmatic embedded" trial). The key feature of our design was that, instead of employing local investigators, the investigators developed centralized trial procedures and implemented into the VA electronic health record (EHR) and healthcare delivery systems. This approach enabled us to conduct trial-related interactions and randomization with the use of data in the EHRs, centralize recruitment efforts without the use of site staff, eliminate the need for trial-related visits and procedures, and centralize data capture from administrative databases.

This study was performed to answer a question of whether chlorthalidone is more effective than hydrochlorothiazide at preventing cardiovascular outcomes. Consent was obtained from eligible participants who were willing to participate and their primary care providers. With provider assented to the patient undergoing randomization, 3,523 older patients with hypertension were randomized across 72 VA health care systems. Patients across the US (including Puerto Rico and District of Columbia) were enrolled. Participants were randomly assigned to continue with existing hydrochlorothiazide treatment regimen (25/50mg daily) or switch to a dose equivalent chlorthalidone (12.5/25 mg daily).

The primary outcome was the first occurrence of a composite outcome consisting of a nonfatal cardiovascular event or non-cancer related death. Nonfatal cardiovascular events included nonfatal myocardial infarction, stroke, hospitalization for heart failure, or urgent coronary revascularization for unstable angina.

Conditions
Hypertension
Being tested
Hydrochlorothiazide (HCTZ), Chlorthalidone (CTD)
Keywords
Hypertension, Cardiovascular outcomes, Pragmatic clinical trial, Point of care research
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrochlorothiazide (HCTZ)Drug

    Also called HCTZ

    Trial activities following study randomization were considered as usual care. Prescriptions of the allocated drug were managed by the primary care providers and patients would receive the prescribed mediations through the VA outpatient pharmacy services.

  • Chlorthalidone (CTD)Drug

    Also called CTD

    Trial activities following study randomization were considered as usual care. Prescriptions of the allocated drug were managed by the primary care providers and patients would receive the prescribed mediations through the VA outpatient pharmacy services.

Study groups in NCT02185417
Study groupRoleWhat they receive
HydrochlorothiazideActive comparatorParticipants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).
Receives: Drug: Hydrochlorothiazide (HCTZ)
ChlorthalidoneActive comparatorParticipants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).
Receives: Drug: Chlorthalidone (CTD)
ProvidersNo interventionProviders were enrolled in order to contact their potentially eligible patients and were not included in the results

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From Randomization to Composite Primary Outcome

    Time to study primary outcome was defined as years from randomization to the first occurrence of a composite endpoint, consisting of a nonfatal cardiovascular event or non-cancer related death. Nonfatal cardiovascular events included nonfatal myocardial infarction, stroke, hospitalization for heart failure, or urgent coronary revascularization for unstable angina. For participants who had a primary outcome, time to event was determined as the earliest admission or death date. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

    Measured: Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

  2. Proportion of Participants Had a Composite Primary Outcome

    The primary outcome was the first occurrence of a composite endpoint consisting of a nonfatal cardiovascular event or non-cancer related death. Nonfatal cardiovascular events included nonfatal myocardial infarction, stroke, hospitalization for heart failure, or urgent coronary revascularization for unstable angina. Time to the first event was computed based on the earliest hospital admission or death dates. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

    Measured: Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

Secondary outcomes (5)

  1. Proportion of Participants Had Nonfatal Myocardial Infarction

    Secondary outcomes were the individual components of the primary outcome. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

    Measured: Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

  2. Proportion of Participants Had Nonfatal Stroke

    Secondary outcomes were the individual components of the primary outcome. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

    Measured: Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

  3. Proportion of Participants Had Hospitalization for Heart Failure

    Secondary outcomes were the individual components of the primary outcome. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

    Measured: Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

  4. Proportion of Participants Had Unstable Angina Leading to Urgent Coronary Revascularization

    Secondary outcomes were the individual components of the primary outcome. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

    Measured: Collection of outcome data were performed from randomization until participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

  5. Proportion of Participants Deceased and Not Related to Cancer

    Secondary outcomes were the individual components of the primary outcome. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

    Measured: Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2014 (estimated)
  2. Study start15 Jun 2016
  3. Primary completion15 Oct 2022
  4. Study completion29 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20,723 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02185417
Sponsor's protocol ID
597
Acronym
DCP
Status last verified
May 2024
First submitted
30 Jun 2014
Last updated
22 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There is no IPD sharing plan description

Publications

  • Ishani A, Leatherman SM, Woods P, Hau C, Klint A, Lew RA, Taylor AA, Glassman PA, Brophy MT, Fiore LD, Ferguson RE, Cushman WC. Design of a pragmatic clinical trial embedded in the Electronic Health Record: The VA's Diuretic Comparison Project. Contemp Clin Trials. 2022 May;116:106754. doi: 10.1016/j.cct.2022.106754. Epub 2022 Apr 4.

    PubMed 35390512

  • Ferguson RE, Leatherman SM, Woods P, Hau C, Lew R, Cushman WC, Brophy MT, Fiore L, Ishani A. Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project. Clin Trials. 2023 Jun;20(3):276-283. doi: 10.1177/17407745231160553. Epub 2023 Mar 29.

    PubMed 36992530

  • Ishani A, Cushman WC, Leatherman SM, Lew RA, Woods P, Glassman PA, Taylor AA, Hau C, Klint A, Huang GD, Brophy MT, Fiore LD, Ferguson RE; Diuretic Comparison Project Writing Group. Chlorthalidone vs. Hydrochlorothiazide for Hypertension-Cardiovascular Events. N Engl J Med. 2022 Dec 29;387(26):2401-2410. doi: 10.1056/NEJMoa2212270. Epub 2022 Dec 14.

    PubMed 36516076

  • Hau C, Efird JT, Leatherman SM, Soloviev OV, Glassman PA, Woods PA, Ishani A, Cushman WC, Ferguson RE. A Centralized EHR-Based Model for the Recruitment of Rural and Lower Socioeconomic Participants in Pragmatic Trials: A Secondary Analysis of the Diuretic Comparison Project. JAMA Netw Open. 2023 Sep 5;6(9):e2332049. doi: 10.1001/jamanetworkopen.2023.32049.

    PubMed 37656456

  • Anand ST, Hau C, Davenport MJ, Ishani A, Cushman WC, Glassman PA, Taylor AA, Lew RA, Ferguson RE, Leatherman SM. Per-Protocol Analysis of Chlorthalidone Versus Hydrochlorothiazide for Cardiovascular Event Prevention-Diuretic Comparison Project. J Am Heart Assoc. 2026 Feb 3;15(3):e046142. doi: 10.1161/JAHA.125.046142. Epub 2026 Jan 30.

    PubMed 41614323

  • Leatherman SM, Beaudette-Zlatanova B, Robben G, Glassman PA, Woods P, Ferguson RE, Cushman WC, Ishani A. Provider experiences with and attitudes about an embedded pragmatic clinical trial. BMC Prim Care. 2025 Apr 23;26(1):121. doi: 10.1186/s12875-025-02799-w.

    PubMed 40269774

  • Ishani A, Hau C, Raju S, Wise JK, Glassman PA, Taylor AA, Ferguson RE, Cushman WC, Leatherman SM. Chlorthalidone vs Hydrochlorothiazide and Kidney Outcomes in Patients With Hypertension: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2449576. doi: 10.1001/jamanetworkopen.2024.49576.

    PubMed 39656458

  • Ishani A, Hau C, Cushman WC, Leatherman SM, Lew RA, Glassman PA, Taylor AA, Ferguson RE. Chlorthalidone vs Hydrochlorothiazide for Hypertension Treatment After Myocardial Infarction or Stroke: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2411081. doi: 10.1001/jamanetworkopen.2024.11081.

    PubMed 38743423

  • Klint AL, Leatherman SM, Taylor O, Glassman PA, Ferguson RE, Cushman WC, Ishani A. Telephone informed consent in a pragmatic point-of-care clinical trial embedded in primary care. Contemp Clin Trials. 2023 Aug;131:107239. doi: 10.1016/j.cct.2023.107239. Epub 2023 May 25.

    PubMed 37244366

  • Raju S, Hau C, Woods P, Flynn M, Sadatis C, McPherson J, Tella A, Ishani A, Ferguson RE, Leatherman SM. Ascertainment of stroke from administrative data to support a pragmatic embedded clinical trial. Contemp Clin Trials. 2023 Jul;130:107214. doi: 10.1016/j.cct.2023.107214. Epub 2023 May 1.

    PubMed 37137378

  • Leatherman SM, Hau C, Klint A, Glassman PA, Taylor AA, Ferguson RE, Cushman WC, Ishani A. The impact of COVID-19 on a large pragmatic clinical trial embedded in primary care. Contemp Clin Trials. 2023 Jun;129:107179. doi: 10.1016/j.cct.2023.107179. Epub 2023 Apr 7.

    PubMed 37031794

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydrochlorothiazide (HCTZ) and Chlorthalidone (CTD) in people with Hypertension, run by VA Office of Research and Development at 70 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to Composite Primary Outcome (time frame: Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02185417, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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