Overactive BladderPhase 3EmpowurNCT03583372
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
A Phase 3 study testing Vibegron and Tolterodine Tartrate ER in people with Overactive Bladder, run by Urovant Sciences GmbH at 107 sites in United States.
Trial summary
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Vibegron and Tolterodine Tartrate ER
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- 107 sitesUnited States
- Study dates
- 14 Jun 2018to 25 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has completed participation in study RVT-901-3003.
- Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.
Who cannot join
- Has a change in history or current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstance that might, in the opinion of the Investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
- Has coronary or neurovascular interventions planned during the duration of the study.
- Has uncontrolled hyperglycemia (defined as fasting blood glucose >150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in study RVT-901-3003 or, if in the opinion of the Investigator, is uncontrolled.
- Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) > 100 beats per minute.
- Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
- Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome) based on most recent available lab results in study RVT-901-3003.
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- Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003.
- Use of any prohibited medications as detailed in Section 7.7.3.
- Plans to initiate or change the dosing of any medications listed in Section 7.7.5 during the study that in the opinion of the investigator is assessed to be clinical significant.
- Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
- Is currently participating or has participated in a study with an investigational compound or device within 28 days of signing informed consent, not including participation in study RVT-901-3003.
- Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
- Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.
Trial locations and contacts
107 sites in 1 country.
107 sites in 1 country
United States107 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
AccumetRx Clinical Research - Division of Urology Group of New Mexico
Albuquerque, New Mexico, 87109
Montana Health Research Institute Inc.
Billings, Montana, 59102
United Medical Associates
Binghamton, New York, 13901
Boston Clinical Trials
Boston, Massachusetts, 02131
PAB Clinical Research
Brandon, Florida, 33511
Investigators Research Group LLC
Brownsburg, Indiana, 46112
DiscoveResearch Inc.
Bryan, Texas, 77802-2589
Seattle Urology Research
Burien, Washington, 98166
Hope Clinical Research
Canoga Park, California, 91303
Core Healthcare Group
Cerritos, California, 90703
Clinical Trials of South Carolina
Charleston, South Carolina, 29406-8106
PMG Research of Charlotte LLC
Charlotte, North Carolina, 28209
Sentral Clinical Research Services
Cincinnati, Ohio, 45236-2934
Rapid Medical Research
Cleveland, Ohio, 44122
Buckeye Health and Research
Columbus, Ohio, 43207
Aventiv Research, Inc.
Columbus, Ohio, 43213-6523
Top Medical Research Inc.
Cutler Bay, Florida, 33189
Providence Health Partners
Dayton, Ohio, 45439
Horizons Clinical Research Center
Denver, Colorado, 80220
Lynn Institute of Denver
Denver, Colorado, 80246
WR Global Medical Research
DeSoto, Texas, 75115-2052
Revival Research
Doral, Florida, 33122
Greater Providence Clinical Research, LLC
East Providence, Rhode Island, 02914
Riverside Clinical Research
Edgewater, Florida, 32132
Premier Urology Group LLC
Edison, New Jersey, 08837
Regional Clinical Research Inc.
Endwell, New York, 13760
Urologic Research and Consulting LLC
Englewood, New Jersey, 07631
HWC Womens Research Center
Englewood, Ohio, 45322-2722
Evanston Premier Healthcare Research
Evanston, Illinois, 60201
Piedmont Research Partners
Fort Mill, South Carolina, 29707
AccuMed Research Associates
Garden City, New York, 11530-1664
PharmQuest
Greensboro, North Carolina, 27408
Clinical Investigation Specialists Inc.
Gurnee, Illinois, 60031
Drug Trials America
Hartsdale, New York, 10530
American Clinical Trials
Hawaiian Gardens, California, 90716
Indago Research Health Center
Hialeah, Florida, 33012
Best Quality Research, Inc.
Hialeah, Florida, 33016
Advances in Health
Houston, Texas, 77030
Pioneer Research Solutions
Houston, Texas, 77099
Protenium Clinical Research
Hurst, Texas, 76054
Leonard Maliver MD Antria, Inc.
Indiana, Pennsylvania, 15701
The Jackson Clinic
Jackson, Tennessee, 38301
The Clinical Trial Center LLC
Jenkintown, Pennsylvania, 19046
MultiSpecialty Clinical Research, Inc.
Johnson City, Tennessee, 37601
Health Awareness, Inc.
Jupiter, Florida, 33458
Grossmont Center for Clinical Research
La Mesa, California, 91942
Barrett Clinic P.C.
La Vista, Nebraska, 68128
Prime-Care Clinical Research
Laguna Hills, California, 92653
Excel Clinical Research
Las Vegas, Nevada, 89109-6209
Lawrence OB-GYN Clinical Research LLC
Lawrenceville, New Jersey, 08648-2526
Central Kentucky Research Associates Inc.
Lexington, Kentucky, 40509
Women's Clinic of Lincoln PC
Lincoln, Nebraska, 68510
Long Beach Clinical Trials LLC
Long Beach, California, 90806
Downtown L.A. Research Center Inc.
Los Angeles, California, 90017
Adams Patterson Gynecology and Obstetrics
Memphis, Tennessee, 38120-2382
Advanced Clinical Research
Meridian, Idaho, 83642
San Marcus Research Clinic Inc.
Miami, Florida, 33015
LCC Medical Research Institute Inc.
Miami, Florida, 33126
Nuren Medical Research Center
Miami, Florida, 33144
AppleMed Research Group LLC
Miami, Florida, 33155
Miami Clinical Research
Miami, Florida, 33155
Advanced Medical Research Institute
Miami, Florida, 33174
Clinical Research Solutions
Middleburg Heights, Ohio, 44130
Clinical Research Consulting LLC
Milford, Connecticut, 06460
Coastal Clinical Research Inc.
Mobile, Alabama, 36608
Tri Valley Urology Medical Group
Murrieta, California, 92562
Family Medicine of SayeBrook LLC
Myrtle Beach, South Carolina, 29588
Coastal Connecticut Research LLC
New London, Connecticut, 06320
DelRicht Research
New Orleans, Louisiana, 70115
Suncoast Clinical Research Inc.
New Port Richey, Florida, 34652
Bayside Clinical Research
New Port Richey, Florida, 34655
Health Research of Hampton Roads Inc.
Newport News, Virginia, 23606
Meridian Clinical Research LLC
Norfolk, Nebraska, 68701
Infinity Medical Research Inc.
North Dartmouth, Massachusetts, 02747
Compass Research LLC
Orlando, Florida, 32806
In-Quest Medical Research, LLC
Peachtree Corners, Georgia, 30071
South Broward Research LLC
Pembroke Pines, Florida, 33027
Clinical Research of Philadelphia LLC
Philadelphia, Pennsylvania, 19114
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, 15236
Research Protocol Management Specialists Hills ObGyn Associates Inc
Pittsburgh, Pennsylvania, 15243
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Remidica LLC
Rochester, Michigan, 48307-1318
Northern California Research
Sacramento, California, 95821
Wasatch Clinical Research LLC
Salt Lake City, Utah, 84107
Clinical Trials of Texas Inc.
San Antonio, Texas, 78229
Bandera Family Health Care
San Antonio, Texas, 78249
Artemis Institute for Clinical Research
San Diego, California, 92103
WR MCCCR
San Diego, California, 92108
Artemis Institute for Clinical Research
San Marcos, California, 92078
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105
Regional Urology LLC
Shreveport, Louisiana, 71106
Hillcrest Clinical Research LLC
Simpsonville, South Carolina, 29681
Palmetto Clinical Research
Summerville, South Carolina, 29485
Clinical Research of West Florida
Tampa, Florida, 33603
Clinical Research Consortium
Tempe, Arizona, 85283
Noble Clinical Research
Tucson, Arizona, 85704
Bayview Research Group LLC
Valley Village, California, 91607-3456
Family Practice Center of Wadsworth Inc. - New Venture Medical Research
Wadsworth, Ohio, 44281
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Bay State Clinical Trials Inc.
Watertown, Massachusetts, 02472
Upstate Clinical Research Associates LLC
Williamsville, New York, 14221-6046
Ohio Clinical Research LLC
Willoughby Hills, Ohio, 44094
PMG Research
Wilmington, North Carolina, 28401
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Clinical Research of Central Florida
Winter Haven, Florida, 33880
North Georgia Clinical Research
Woodstock, Georgia, 30189-4255
About this study
Official title: An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.
- Conditions
- Overactive Bladder
- Being tested
- Vibegron, placebos, Tolterodine Tartrate ER
- Keywords
- Beta-3 adrenergic receptor (β3-AR) agonists, incontinence, OAB, vibegron, urge urinary incontinence, Urinary bladder, overactive, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Agents
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urologic Diseases, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibegronDrug
Also called RVT-901, MK-4618, KRP114V
single daily dose 75 mg
placebosDrug
placebo to match vibegron (experimental drug) and tolterodine (active comparator)
Tolterodine Tartrate ERDrug
Also called Mariosea XL
single daily dose of 4 mg
| Study group | Role | What they receive |
|---|---|---|
| Vibegron + Placebo to match Tolterodine | Experimental | Not described Receives: Drug: Vibegron; Drug: placebos |
| Tolterodine + Placebo to match vibegron | Active comparator | Not described Receives: Drug: placebos; Drug: Tolterodine Tartrate ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.
Measured: up to 56 weeks
Secondary outcomes (4)
Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
A micturition/void is defined as "Urinated in Toilet" as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated in the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
Measured: Baseline; Week 52
CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only participants with evaluable data were analyzed.
Measured: Baseline; Week 52
CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants
The number of urgency episodes is defined as the number of times a participant had checked "need to urinate immediately" on a CDD divided by the number of CDDs in the PVD. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
Measured: Baseline; Week 52
CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants
The number of total incontinence episodes is defined as the number of times a participant had checked the accidental urine leakage box in the PVD, including for reasons of "urge," "stress," or "other." CFB was calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hour.
Measured: Baseline; Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start14 Jun 2018
- Primary completion13 Jun 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583372
- Sponsor's protocol ID
- RVT-901-3004
- Other IDs
- 2017-003294-33, 2017
- Acronym
- Empowur
- Status last verified
- Feb 2021
- First submitted
- 28 Jun 2018
- Last updated
- 18 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR). J Urol. 2021 May;205(5):1421-1429. doi: 10.1097/JU.0000000000001574. Epub 2020 Dec 28.
PubMed 33356445
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
- ClinicalTrials.gov ID
- NCT03583372
- Acronym / sponsor ID
- Empowur / RVT-901-3004
- Conditions
- Overactive Bladder
- Keywords
- Beta-3 adrenergic receptor (β3-AR) agonists, incontinence, OAB, vibegron, urge urinary incontinence, Urinary bladder, overactive, Urologic Diseases, Lower Urinary Tract Symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Urovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Posted 3 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibegron + Placebo to match Tolterodine | Experimental | Drug: Vibegron, Drug: placebos |
| Tolterodine + Placebo to match vibegron | Active comparator | Drug: placebos, Drug: Tolterodine Tartrate ER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has completed participation in study RVT-901-3003.
- Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.
Key exclusion criteria (13 listed)
- Has a change in history or current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstance that might, in the opinion of the Investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
- Has coronary or neurovascular interventions planned during the duration of the study.
- Has uncontrolled hyperglycemia (defined as fasting blood glucose >150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in study RVT-901-3003 or, if in the opinion of the Investigator, is uncontrolled.
- Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) > 100 beats per minute.
- Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibegronAlso: RVT-901, MK-4618, KRP114Vsingle daily dose 75 mg | Drug | Vibegron + Placebo to match Tolterodine |
| placebosplacebo to match vibegron (experimental drug) and tolterodine (active comparator) | Drug | Tolterodine + Placebo to match vibegron, Vibegron + Placebo to match Tolterodine |
| Tolterodine Tartrate ERAlso: Mariosea XLsingle daily dose of 4 mg | Drug | Tolterodine + Placebo to match vibegron |
Primary outcome
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
Time frame: up to 56 weeks
Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.
4 secondary outcomes
Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
Time frame: Baseline; Week 52
CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
Time frame: Baseline; Week 52
CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants
Time frame: Baseline; Week 52
CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants
Time frame: Baseline; Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33356445Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR). J Urol. 2021 May;205(5):1421-1429. doi: 10.1097/JU.0000000000001574. Epub 2020 Dec 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
107 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vibegron and Tolterodine Tartrate ER in people with Overactive Bladder, run by Urovant Sciences GmbH at 107 sites in United States.
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 2 inclusion and 13 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 sites in United States. 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 3 Feb 2021). 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?
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event (time frame: up to 56 weeks). 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 NCT03583372, which also lists 1 linked publication.
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 18 Mar 2021.