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Overactive BladderPhase 3NCT03902080

Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

A Phase 3 study testing Vibegron in people with Overactive Bladder, run by Urovant Sciences GmbH at 140 sites in 8 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

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes. Read more about this study

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Overactive Bladder
What is being tested?
Vibegron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,105 participants
Where
140 sitesin 8 countries
Study dates
26 Mar 2019to 15 Jun 2023
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 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant should have been on and agree to continue to stay on a stable dose of benign prostatic hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 alpha reductase inhibitor.
  • Participant has an International Prostate Symptom Score total score of ≥ 8
  • Participant has a prostate-specific antigen level < 4 nanograms per milliliter (ng/mL), or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator
  • Participant must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day over the 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per day over the 3-day diary period
  • Participant must have a post void residual volume value of < 100 mL
  • Having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.

Who cannot join

  • Participant has a history of 24-hour urine volume greater than 3,000 mL
  • Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence
  • Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery
  • Has a history of urinary retention requiring an intervention (e.g., catheterization) for any reason
  • Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL
  • Has a history of or current nocturnal polyuria
Show all 13Show fewer
  • Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or laboratory criteria (≥ 5 white blood cells/high power field [hpf] with presence of red blood cell [RBC] and/or a positive urine culture, defined as ≥ 10^5 colony forming units (CFU)/mL (i.e., 100 × 10^3 CFU/mL in a single specimen)
  • Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 milligrams per deciliter (mg/dL) or 8.33 millimoles per liter (mmol/L) or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled
  • Has uncontrolled hypertension (systolic blood pressure of ≥ 180 millimeters of mercury (mmHg) and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute (min)
  • Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit
  • Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 × ULN (or > 2.0 × ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome)
  • Has an estimated glomerular filtration rate < 30 mL/min/1.73 meters squared (m^2)
  • Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with the study procedure, or make participation in the study not in the participant's best interest

Trial locations and contacts

140 sites in 8 countries.

140 sites in 8 countries

United States75 sites

  • Albany Medical College

    Albany, New York, 12208

  • Chesapeake Urology Research Associates

    Baltimore, Maryland, 21204

  • Boston Clinical Trials Inc - Urology

    Boston, Massachusetts, 02131

  • Imagine Research of Palm Beach County - Urology

    Boynton Beach, Florida, 33435

  • Western New York Urology Associates

    Buffalo, New York, 14203

  • Seattle Urology Research Center

    Burien, Washington, 98166

  • Mens Health Boston - Urology

    Chestnut Hill, Massachusetts, 02467

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • Urology Associates - Urology

    Denver, Colorado, 80220

  • Duke Medical Center - Urology

    Durham, North Carolina, 27710

  • Premier Urology Group, LLC

    Edison, New Jersey, 08837

  • New Jersey Urology NJU

    Englewood, New Jersey, 07631

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 27612

  • California Research Medical Group, Inc.

    Fullerton, California, 92835

  • AccuMed research Asociates

    Garden City, New York, 11530

  • Urological Surgeons of Long Island

    Garden City, New York, 11530

  • Gen1 Research- Arizona Urology Specialists

    Glendale, Arizona, 85308

  • NorthShore University Health System

    Glenview, Illinois, 60153

  • Alliance Urology Specialists - Greensboro

    Greensboro, North Carolina, 27403

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Urological Research Network Corp

    Hialeah, Florida, 33016

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • Advances In Health, Inc.

    Houston, Texas, 77030

  • Private Practice

    Huntsville, Alabama, 35801

  • First Urology

    Jeffersonville, Indiana, 47130

  • San Diego Clinical Trials

    La Mesa, California, 91942

  • Excel Clinical Research - Internal Medicine

    Las Vegas, Nevada, 89109

  • Private Practice

    Las Vegas, Nevada, 89148

  • Clinical Trials Research

    Lincoln, California, 95648

  • West Coast Urology

    Los Alamitos, California, 90720

  • American Institute of Research

    Los Angeles, California, 90017

  • Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Idaho Urologic Institute

    Meridian, Idaho, 83642

  • LCC Medical Research Institute

    Miami, Florida, 33126

  • Quantum Clinical Trials

    Miami, Florida, 33140

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • New Jersey Urology, LLC

    Mount Laurel, New Jersey, 08054

  • Tri Valley Urology Medical Group

    Murrieta, California, 92562

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • Manhattan Research Associates

    New York, New York, 10016

  • Columbia University Medical Center - Clinical Research

    New York, New York, 10032

  • Weill Cornell Medicine

    New York, New York, 10065

  • Lowcountry Urology

    North Charleston, South Carolina, 29406

  • Adult & Pediatric Urology P.C. - Urology

    Omaha, Nebraska, 68114

  • Private Practice

    Orlando, Florida, 32808

  • Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)

    Plainview, New York, 11803

  • Urology Center Of Florida

    Pompano Beach, Florida, 33060

  • Poplar Bluff Urology

    Poplar Bluff, Missouri, 63901

  • Private Practice

    Poughkeepsie, New York, 12603

  • Associated Urologists of North Carolina - Urology

    Raleigh, North Carolina, 27612

  • Beaumont Hospital Royal Oak - Urology Research

    Royal Oak, Michigan, 48703

  • Northern California Research Corp

    Sacramento, California, 95821

  • Wasatch Clinical Research LLC

    Salt Lake City, Utah, 84107

  • Urology San Antonio

    San Antonio, Texas, 78229

  • Discovery Clinical Trials

    San Antonio, Texas, 78258

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • CentraCare Clinic - Adult & Pediatric Urology

    Sartell, Minnesota, 56377

  • Meridian Clinical Research - Urology

    Savannah, Georgia, 31405

  • Urology Specialists of Southern California (USSC)

    Sherman Oaks, California, 91411

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Pinellas Urology, Inc.

    St. Petersburg, Florida, 33710

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • Florida Urology Partners, LLP

    Tampa, Florida, 33615

  • Baylor Scott & White Medical Center

    Temple, Texas, 76508

  • Skyline Urology

    Torrance, California, 90505

  • Urological Associates Of Southern Arizona

    Tucson, Arizona, 85741

  • Urology of Virginia (UVA)

    Virginia Beach, Virginia, 23462

  • New Jersey Urology, LLC

    Voorhees Township, New Jersey, 08043

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts, 02472

  • The Iowa Clinic

    West Des Moines, Iowa, 50266

  • GU Research Network/Wichita Urology Group

    Wichita, Kansas, 67226

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

Other trials in United States

Poland13 sites

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-650

  • Centrum Medyczne PROMED

    Krakow, Malopolskie Województwo, 31-513

  • Centrum Medyczne Linden

    Krakow, 37-721

  • NZOZ Specjalista

    Kutno, Lódzkie, 99-300

  • ETG Lodz

    Lodz, Lódzkie, 90-302

  • Centrum Urologiczne sp. z o.o.

    Mysłowice, Silesian Voivodeship, 41-400

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • Nzoz Heureka

    Piaseczno, 05-500

  • Clinical Research Center Sp. z o.o., Medic-R Sp. K.

    Poznan, Greater Poland Voivodeship, 60-856

  • Szpital Specjalistyczny Slupsk

    Słupsk, Pomeranian Voivodeship, 76-200

  • EuroMediCare Szpital Specjalistyczny z Przychodnia

    Wroclaw, Dolnoslaskie Województwo, 54-144

  • Wojewodzki Szpital Specjalist

    Wroclaw, Lower Silesian Voivodeship, 51-124

  • Lexmedica Hanna Durbajlo-Gradziel

    Wroclaw, 53-114

Other trials in Poland

Spain13 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario HM Monteprincipe

    Boadilla del Monte, Madrid, 28660

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Clínica Universitaria de Navarra

    Madrid, 28027

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital General Universitario Gregorio Marañón

    Majadahonda, Madrid, 28007

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • H.U. Virgen de la Victoria

    Málaga, 29010

  • Hospital Santiago Apostol

    Miranda de Ebro, Burgos, 09200

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Lithuania10 sites

  • Kaunas Hospital of Lithuanian Universoity of Health Sciences

    Kaunas, Kaunas County, LT-47144

  • JSC Saules seimos medicinos centras

    Kaunas, Kaunas County, LT-49449

  • Uab "Vakk"

    Kaunas, Kaunas County, LT-50128

  • Hospital of University of Health Sciences Kauno Klinikos

    Kaunas, Kaunas County, LT-50161

  • Respublikine Klaipedos ligonine - Urology

    Klaipėda, Klaipėda County, LT-92231

  • Klaipedos Universitetine Ligonine (Klaipeda Hospital)

    Klaipėda, Klaipėda County, LT-92288

  • National Cancer Institute

    Vilnius, Vilnius County, LT-08660

  • Republican Vilnius University Hospital

    Vilnius, Vilnius County, LT-08660

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, Vilnius County, LT-08661

  • Vilnius City Clinical Hospital

    Vilnius, Vilnius County, LT-10207

Other trials in Lithuania

Canada8 sites

  • Private Practice

    Brampton, Ontario, L6T 4S5

  • Diex Research Quebec Inc.

    Québec, Quebec, G1N 4V3

  • Bluewater Clinical Research Group Inc

    Sarnia, Ontario, N7T 4X3

  • Centre Hospitalier Universitaire De Sherbrooke (CHUS)

    Sherbrooke, Quebec, J1H 5N4

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Diex Research Victoriaville Inc.

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Hungary8 sites

  • Semmelweis Egyetem

    Budapest, 01082

  • Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

    Budapest, 01204

  • Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny

    Csongrád, 06640

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

    Nyíregyháza, 04400

  • Uro-Clin Kft.

    Pècs, 07621

  • DRC Kft.

    Sopron, Győr-Moson-Sopron, H-9400

  • University of Szeged

    Szeged, Csongrád megye, 06725

  • Szent Borbala Korhaz

    Tatabánya, 02800

Other trials in Hungary

Belgium7 sites

  • Algemeen Stedelijk Ziekenhuis

    Aalst, Oost-Vlaanderen, 09300

  • Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst

    Aalst, Oost-Vlaanderen, 09300

  • Uz Antwerpen

    Edegem, Antwerpen, 02650

  • AZ Maria Middelares - Campus Maria Middelares

    Ghent, Oost-Vlaanderen, 09000

  • UZ Leuven - Campus Gasthuisberg

    Leuven, Vlaams Brabant, 03000

  • CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie

    Liège, 04000

  • AZ Delta - Campus Wilgenstraat

    Roeselare, West-Vlaanderen, 08800

Other trials in Belgium

Portugal6 sites

  • Hospital Garcia de Orta

    Almada, 2805-267

  • Centro Clínico Académico Braga, Hospital de Braga

    Braga, 4710-243

  • Hospital Senhora de Oliveiro Guimaraes EPE

    Guimarães, 4835-044

  • H. Egas Moniz. Centro Hospitalar Lisboa Ocidental

    Lisbon, 1349-019

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • H. Santo António. Centro Hospitalar do Porto

    Porto, 4099-001

Other trials in Portugal

About this study

Official title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

Being tested
Vibegron, Placebo
Keywords
Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (ß3-AR), ß3-AR agonist
Medical subject headings
Urinary Bladder, Overactive, Prostatic Hyperplasia

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, KRP-114V, URO-901

    oral administration

  • PlaceboDrug

    oral administration

Study groups in NCT03902080
Study groupRoleWhat they receive
Vibegron 75 mgExperimentalParticipants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
Receives: Drug: Vibegron
PlaceboPlacebo comparatorParticipants will receive matching placebo orally once daily for 24 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day

    Micturition was defined as the number of times a participant voided in the toilet as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.

    Measured: Baseline; Week 12

  2. Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day

    Urgency was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.

    Measured: Baseline; Week 12

Secondary outcomes (4)

  1. Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night

    Nocturia was defined as waking to pass urine during the main sleep period. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value.

    Measured: Baseline; Week 12

  2. Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline

    The number of UUI episodes was defined as the number of times a subject checked that they had "urge" as the main reason for leakage. Average UUI episodes per day at each study visit was calculated as total number of UUI episodes within the diary analysis visit windows divided by non-missing diary days. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.

    Measured: Baseline; Week 12

  3. Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)

    The IPSS is based on the responses to 7 questions concerning urinary symptoms and 1 question concerning quality of life. Each question concerning urinary symptoms allows the participant to choose 1 out of 6 answers indicating increasing severity of the particular symptom. The responses are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher numerical scores represent greater severity of symptoms. Decrease in IPSS storage score indicates improvement. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value.

    Measured: Baseline; Week 12

  4. Change From Baseline at Week 12 in the Average Volume Voided Per Micturition

    Micturition was defined as the number of times a participant voided in the toilet as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Average volume voided per micturition at each study visit was calculated as the total volume voided over diary days within the analysis visit window divided by the total number of micturition episodes during non-missing diary days.

    Measured: Baseline; Week 12

Timeline

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

  1. First posted3 Apr 2019
  2. Study start26 Mar 2019
  3. Primary completion15 Jun 2023
  4. Study completion15 Jun 2023

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03902080
Sponsor's protocol ID
URO-901-3005
Other IDs
2018-003135-30, 2018
Status last verified
Jun 2024
First submitted
1 Apr 2019
Last updated
7 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.

Publications

  • Rovner ES, Owens-Grillo J, Thomas E, Herschorn S, Peters KM, Staskin D, Mujais S. Bladder Function and Safety of Vibegron in Men With Overactive Bladder Receiving Treatment for Benign Prostatic Hyperplasia: Outcomes From the Phase 3 Randomized Controlled COURAGE Trial. Neurourol Urodyn. 2026 Feb;45(2):299-304. doi: 10.1002/nau.70199. Epub 2025 Dec 9.

    PubMed 41363221

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vibegron in people with Overactive Bladder, run by Urovant Sciences GmbH at 140 sites in 8 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 6 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Poland, Spain, Lithuania, Canada and 3 more countries. 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. Some participants in this study may receive a placebo. 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 7 Aug 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?

Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day (time frame: Baseline; Week 12). 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 NCT03902080, 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 7 Aug 2024.

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