Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure (STANDUP AHF)

December 11, 2020 updated by: Bristol-Myers Squibb

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function

A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
329

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
      • Cordoba, Argentina
        • Local Institution
      • Cordoba, Argentina, X5000JHQ
        • Local Institution
      • Cordoba, Argentina, X5000AAX
        • Local Institution
      • Cordoba, Argentina, X5000EPU
        • Local Institution
      • Corrientes, Argentina, 3400
        • Local Institution
      • Santa Fe, Argentina, 3000
        • Local Institution
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1428ART
        • Local Institution
    • Santa FE
      • Rosario, Santa FE, Argentina, Santa Fe, 2000
        • Local Institution
  • Canada
      • Quebec, Canada, G1V 4G5
        • Local Institution
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • Local Institution
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4S9
        • Local Institution
  • Czechia
      • Brno, Czechia, 656 91
        • Local Institution
      • Brno, Czechia, 625 00
        • Local Institution
      • Hradec Kralove, Czechia, 500 05
        • Local Institution
      • Plzen-Bory, Czechia, 305 99
        • Local Institution
      • Prague, Czechia, 12808
        • Local Institution
      • Praha 4, Czechia, 140 21
        • Local Institution
      • Slany, Czechia, 274 01
        • Local Institution
  • France
      • Besancon, France, 25000
        • Local Institution
      • Beziers, France, 34500
        • Local Institution
      • Bobigny, France, 93009
        • Local Institution
      • Creteil, France
        • Local Institution
      • Evreux, France, 27015
        • Local Institution
      • La Tronche, France, 38700
        • Local Institution
      • Paris, France, 75013
        • Local Institution
      • Paris Cedex 10, France, 75475
        • Local Institution
  • Germany
      • Bad Nauheim, Germany, 61231
        • Local Institution
      • Frankfurt, Germany, 60590
        • Local Institution
      • Gottingen, Germany, 37075
        • Local Institution
      • Greifswald, Germany
        • Local Institution
      • Hamburg, Germany, 20246
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Homburg, Germany, 66421
        • Local Institution
      • Ludwigshafen, Germany, 67063
        • Local Institution
      • Mainz, Germany
        • Local Institution
      • Regensburg, Germany, 935053
        • Local Institution
  • Greece
      • Athens, Greece, 11527
        • Local Institution
      • Athens, Greece, 12464
        • Local Institution
      • Athens, Greece, 14233
        • Local Institution
      • Athens, Attiki, Greece, 11527
        • Local Institution
      • Ioannina, Greece, 45500
        • Local Institution
      • Kallithea, Greece, 17674
        • Local Institution
      • Larisa, Greece, 41110
        • Local Institution
      • Thessaloniki, Greece, 54636
        • Local Institution
  • Italy
      • Brescia, Italy, 25123
        • Local Institution
      • Ferrara, Italy, 44121
        • Local Institution
      • Foggia, Italy, 71121
        • Local Institution
  • Japan
      • Osaka, Japan, 558-8558
        • Local Institution
      • Tokyo, Japan, 162-8655
        • Local Institution
      • Tokyo, Japan, 113-8655
        • Local Institution
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4678602
        • Local Institution
      • Seto, Aichi, Japan, 489-0065
        • Local Institution
    • Fukushima
      • Fukushima-shi, Fukushima, Japan, 9601295
        • Local Institution
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution
    • Hyogo
      • Amagasaki, Hyogo, Japan, 6608550
        • Local Institution
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 2520375
        • Local Institution
      • Yokohama, Kanagawa, Japan, 232-0024
        • Local Institution
      • Yokohama, Kanagawa, Japan, 227-8501
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution
    • Osaka
      • Suita-shi, Osaka, Japan
        • Local Institution
    • Saitama
      • Kawaguchi, Saitama, Japan, 333-0842
        • Local Institution
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138431
        • Local Institution
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Local Institution
      • Itabashi-ku, Tokyo, Japan, 1738610
        • Local Institution
  • Netherlands
      • Amersfoort, Netherlands, 3818 ES
        • Local Institution
      • Deventer, Netherlands, 7416 SE
        • Local Institution
      • Hardenberg, Netherlands, 7772 SE
        • Local Institution
      • Leeuwarden, Netherlands, 8934 AD
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-276
        • Local Institution
      • Katowice, Poland, 40-635
        • Local Institution
      • Krakow, Poland, 31-202
        • Local Institution
      • Lodz, Poland, 91-347
        • Local Institution
      • Lodz, Poland, 92-213
        • Local Institution
      • Warszawa, Poland, 04-628
        • Local Institution
      • Wroclaw, Poland, 50-981
        • Local Institution
      • Wroclaw, Poland, 54-049
        • Local Institution
      • Zamosc, Poland, 22-400
        • Local Institution
  • Spain
      • Alicante, Spain, 03010
        • Local Institution
      • Barcelona, Spain, 08025
        • Local Institution
      • Barcelona, Spain, 8035
        • Local Institution
      • L'Hospitalet de Llobregat, Spain, 08907
        • Local Institution
      • Madrid, Spain, 28041
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Sant Joan Despi, Spain, 08970
        • Local Institution
      • Santiago De Compostela, Spain, 15706
        • Local Institution
  • United Kingdom
      • Belfast, United Kingdom, BT16 1RH
        • Local Institution
      • Blackpool, United Kingdom, FY3 8NR
        • Local Institution
      • Glasgow, United Kingdom, G4 0SF
        • Local Institution
      • Glasgow, United Kingdom, G51 4TF
        • Local Institution
      • London, United Kingdom, SW17 0QT
        • Local Institution
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Sarver Heart Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Methodist Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Harper University Hospital
      • Detroit, Michigan, United States, 48235
        • Sinai Grace Hospital
      • Detroit, Michigan, United States, 48201
        • DMC Detroit Receiving Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Columbus, Ohio, United States, 43210
        • Wexner Medical Center at the Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina - PPDS
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Actively being hospitalized for acute decompensated heart failure
  • At least 1 administration of IV diuretic for the current episode
  • Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II
  • Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic
  • Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%

Exclusion Criteria:

  • Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm
  • Have an active infection requiring IV anti-microbial treatment
  • Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening
  • Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening
  • Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)

Other protocol defined inclusion/exclusion criteria could apply

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Cohort 1 HNO Donor
Drug: HNO Donor
Infusion
Other Names:
  • BMS-986231
Placebo Comparator: Placebo Part 1 Cohort 1
Drug: Placebo
Infusion
Experimental: Part 2 Cohort 2 HNO Donor- low dose
Drug: HNO Donor
Infusion
Other Names:
  • BMS-986231
Experimental: Part 2 Cohort 2 HNO Donor- high dose
Drug: HNO Donor
Infusion
Other Names:
  • BMS-986231
Placebo Comparator: Placebo Part 2 Cohort 2
Drug: Placebo
Infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion
Time Frame: From start of infusion up to 6 hours post end of infusion
Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) < 90 mm Hg (confirmed by a repeated value < 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion
From start of infusion up to 6 hours post end of infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32
Time Frame: 0, 24, 48, 72, 120 hour or discharge; Day 32
Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)
0, 24, 48, 72, 120 hour or discharge; Day 32
Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72
Time Frame: Hours 6, 12, 24, 48, and 72

Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72.

Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10).

The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor.

A score of 0 represents "I am not breathless at all" and 10 represents "I am the most breathless I can possibly imagine".
Hours 6, 12, 24, 48, and 72
Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion
Time Frame: From start of infusion up to 6 hours post end of infusion
The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.
From start of infusion up to 6 hours post end of infusion
Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)
Time Frame: From start of infusion up to 6 hours post end of infusion
The percentage of participants experiencing SBP < 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.
From start of infusion up to 6 hours post end of infusion
Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32
Time Frame: 32 days

Number of participants who experienced an in-study SAE.

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.
32 days
Number of Participants Who Discontinued Due to Hypotension
Time Frame: up to 120 hours (for AEs); up to 32 days (for SAEs)

Number of participants who discontinued study treatment due to hypotension.

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.

Hypotension defined as systolic blood pressure (SBP) < 90 mmHg.
up to 120 hours (for AEs); up to 32 days (for SAEs)
Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure
Time Frame: up to 120 hours (for AEs); up to 32 days (for SAEs)

Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below.

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.

If the participant experienced systolic blood pressure (SBP) < 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained < 95 mm Hg, the dose reduction occurred.
up to 120 hours (for AEs); up to 32 days (for SAEs)
Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours
Time Frame: up to 120 hours

Number of participants who experienced an in-study AE.

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.
up to 120 hours
Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182
Time Frame: through 182 days

Number of participants who died (all- cause and CV related) through Day 182.

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

CV=Cardiovascular
through 182 days
Change in Troponin T From Baseline to Hour 24, 48, and 72
Time Frame: from baseline to Hour 24, 48, and 72
Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug
from baseline to Hour 24, 48, and 72
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology
Time Frame: to 120 hours

Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in > 5% of total participants).

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
to 120 hours
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry
Time Frame: to 120 hours

Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in > 5% of total participants).

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
to 120 hours
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis
Time Frame: to 120 hours

Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in > 5% of total participants).

Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
to 120 hours
Change in Vital Signs From Baseline to 120 Hours - Blood Pressure
Time Frame: to 120 hours
The change in baseline for vital signs was reported for each arm.
to 120 hours
Change in Vital Signs From Baseline to 120 Hours - Heart Rate
Time Frame: to 120 hours
The change in baseline for vital signs was reported for each arm.
to 120 hours
Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate
Time Frame: to 120 hours
The change in baseline for vital signs was reported for each arm.
to 120 hours
Change in Vital Signs From Baseline to 120 Hours - Temperature
Time Frame: to 120 hours
The change in baseline for vital signs was reported for each arm.
to 120 hours
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate
Time Frame: to 120 hours
The change in baseline for ECGs was reported for each arm.
to 120 hours
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration
Time Frame: to 120 hours
The change in baseline for ECGs was reported for each arm.
to 120 hours
Change in Physical Measurements From Baseline to 120 Hours
Time Frame: to 120 hours
The change in baseline for physical measurements was reported for each arm.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
to 120 hours
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion
Time Frame: to 120 hours
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
to 120 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV013-011
  • 2016-001685-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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