Uterine FibroidsPhase 3ASTEROID 6NCT03194646
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids, run by Bayer at 219 sites in 13 countries.
Trial summary
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Vilaprisan (BAY1002670)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,272 participants
- Where
- 219 sitesin 13 countries
- Study dates
- 30 Jun 2017to 11 Jul 2024
- Phase
- Phase 3
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
- At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
- Good general health
- Normal or clinically insignificant cervical smear
- An endometrial biopsy performed during the screening period, without significant histological disorder
- Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
Who cannot join
- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- Hypersensitivity to any ingredient of the study drug
- Any condition requiring immediate blood transfusion
- Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Abuse of alcohol, drugs, or medicines (eg, laxatives)
- Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- Undiagnosed abnormal genital bleeding
Trial locations and contacts
219 sites in 13 countries.
219 sites in 13 countries
United States94 sites
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, 87109
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
Atlanta Women's Research Institute, Inc. - Atlanta
Atlanta, Georgia, 30342
Medisense Inc at Atlantic Station
Atlanta, Georgia, 30364
Augusta University Medical Center
Augusta, Georgia, 30912
Clinical Inquest Center, Ltd.
Beavercreek, Ohio, 45431
Central Research Associates | Birmingham, AL
Birmingham, Alabama, 35205
Helix Biomedics LLC | Boynton Beach, FL
Boynton Beach, Florida, 33435
SUNY Downstate Health Sciences University - Neurology
Brooklyn, New York, 11203
MUSC Women's Health - Cannon St.
Charleston, South Carolina, 29425
Atrium Health Fertility Center
Charlotte, North Carolina, 28204
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Paramount Research Solutions | College Park Location
College Park, Georgia, 30349
Johns Hopkins University School of Medicine
Columbia, Maryland, 21044
Vista Clinical Research
Columbia, South Carolina, 29201
MultiCare Women's Health - Covington
Covington, Washington, 98042
Discovery Clinical Trials - Dallas
Dallas, Texas, 75231
Miami Valley Hospital - Gynecology
Dayton, Ohio, 45409
Wayne State University Physicians Group
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Doral Medical Research
Doral, Florida, 33166
Carolina Women's Research & Wellness Center
Durham, North Carolina, 27713
Diagnamics | Encinitas, CA
Encinitas, California, 92024
HWC Women's Research Center | Englewood, OH
Englewood, Ohio, 45322
M & O Clinical Research, LLC
Fort Lauderdale, Florida, 33316
Office of Dr. Delbert Alan Johns, MD
Fort Worth, Texas, 76104
Signature Gyn Services
Fort Worth, Texas, 76104
OB-GYN Physicians, Inc.
Franklin, Virginia, 23851
Unified Women's Clinical Research - Greensboro
Greensboro, North Carolina, 27408
VitaLink Research - Greenville
Greenville, South Carolina, 29615
Advanced Women's Health Institute | Denver Office, Greenwood Village, CO
Greenwood Village, Colorado, 80111
Penn State Milton S. Hershey Medical Center - Radiology
Hershey, Pennsylvania, 17033
ClinSearch, LLC
Hixson, Tennessee, 37421
Advances in Health, INC. | Houston, TX
Houston, Texas, 77030
The Woman's Hospital of Texas
Houston, Texas, 77054
MacArthur Medical Center - OB/GYN
Irving, Texas, 75062
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256
Grossmont Center for Clinical Research
La Mesa, California, 91942
Centex Studies, Inc.
Lake Charles, Louisiana, 70601
Physicians' Research Options, LLC | Red Rocks OBGYN
Lakewood, Colorado, 80228
AdventHealth Family Medicine Clinic Lampasas
Lampasas, Texas, 76550
M3 Wake Research - Clinical Research Center of Nevada
Las Vegas, Nevada, 89123
Capital Health | Capital Health OBGYN Lawrenceville
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln, P.C. | Lincoln, NE
Lincoln, Nebraska, 68510
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204
University of Arkansas for Medical Sciences - Neurology
Little Rock, Arkansas, 72205
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, 33470
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072
Women's Physician Group
Memphis, Tennessee, 38104
Southern Clinical Research Associates
Metairie, Louisiana, 70001
Women's Health Alliance of Mobile
Mobile, Alabama, 36604
AMR - Mobile, AL
Mobile, Alabama, 36608
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina, 28557
Venus Gynecology, LLC | Myrtle Beach, SC
Myrtle Beach, South Carolina, 29572
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Eastern Carolina Women's Center | New Bern, NC
New Bern, North Carolina, 28562
Yale University School of Medicine
New Haven, Connecticut, 06511
Integrated Medical Professionals
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Tidewater Clinical Research - Norfolk
Norfolk, Virginia, 23502
Virginia Physicians For Women
North Chesterfield, Virginia, 23235
Research Integrity, LLC
Owensboro, Kentucky, 42303
Suncoast Clinical Research - Palm Harbor
Palm Harbor, Florida, 34684
Center For Women's Care
Palos Heights, Illinois, 60463
Drexel University College of Medicine - Obstetrics and Gynecology
Philadelphia, Pennsylvania, 19102
Hospital of the University of Pennsylvania -
Philadelphia, Pennsylvania, 19104
Clinical Research Philadelphia | Philadelphia, PA
Philadelphia, Pennsylvania, 19114
Baltimore Suburban Health, LLC
Pikesville, Maryland, 21208
Willowbend Health and Wellness Associates
Plano, Texas, 75093
OHSU Hospital - Neurology
Portland, Oregon, 97239
Women's Health Alliance
Raleigh, North Carolina, 27607
M3 Wake Research | Raleigh, NC
Raleigh, North Carolina, 27612
Clinical Trials of Viriginia
Richmond, Virginia, 23225
Synexus Research, LLC
Richmond, Virginia, 23226
ONCOVA Clinical Research, Inc.
Saint Cloud, Florida, 34769
Seven Oaks Women's Center - Main Office - Medical Center
San Antonio, Texas, 78229
M3 Wake Research San Diego - Alvarado
San Diego, California, 92108
Women's Health Care Research | San Diego, CA
San Diego, California, 92111
West Coast OB/GYN Associates
San Diego, California, 92123
Swor Women's Care
Sarasota, Florida, 34239
Fellows Research Alliance, Inc | Savannah, GA
Savannah, Georgia, 31406
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118
Journey Medical Research
Snellville, Georgia, 30078
Stamford Hospital
Stamford, Connecticut, 06904
Richmond ObGyn Associates PC
Staten Island, New York, 10306
Continental Clinical Solutions | Towson, MD
Towson, Maryland, 21204
Suncoast Clinical Research - New Port Richey
Trinity, Florida, 34655
Visions Clinical Research - Tucson
Tucson, Arizona, 85712
IntimMedicine | Washington, DC
Washington D.C., District of Columbia, 20036
Biocentric Health Resarch
West Columbia, South Carolina, 29169
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Valaoras & Lewis OB/GYN
Winston-Salem, North Carolina, 27103
Japan45 sites
Sei Womens Clinic
Bunkyo, Tokyo, 112-0014
Ginza Yoshida Clinic
Chuo-ku, Tokyo, 104-0061
Women's wellness Tsushima Ruriko josei life clinic Ginza
Chuo-ku, Tokyo, 104-0061
St.Luke's International Hospital
Chuoku, Tokyo, 104-8560
Primo Women's Clinic
Ebetsu, Hokkaido, 067-0031
Akazawa Clinic
Fuchū, Tokyo, 183-0056
Kato Internal medicine and Gynecology Clinic
Fukui, 910-0845
Sano Wemen's Clinic
Fukuoka, 810-0062
Kyoritsu Narashinodai Hospital
Funabashi, Chiba, 274-0063
Medical Corp. Seikoukai New Medical Research System Clinic
Hachiōji, Tokyo, 192-0046
Aso Iizuka Hospital
Iizuka, Fukuoka, 820-8505
Unoki Clinic
Kagoshima, 892-0826
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530
Second Kawasaki Saiwai Clinic
Kawasaki, Kanagawa, 212-0021
Jusendo Geneal Hospital Yuasa Foundation
Kōriyama, Fukushima, 963-8585
Kurashiki Medical Clinic
Kurashiki, Okayama-ken, 710-0824
Juno Vesta Clinic Hatta
Matsudo, Chiba, 270-2267
Toranomon Womens Clinic
Minato, Tokyo, 105-0001
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
Minato, Tokyo, 107-0051
Shirokane Ladies' Clinic
Minato, Tokyo, 108-0071
Yokokura Clinic
Minato-ku, Tokyo, 108-0014
Kano's Clinic for Women
Nagoya, Aichi-ken, 460-0011
Fuyo Association Seirei Numazu Hospital
Numazu, Shizuoka, 410-8555
Medical corporation keizukai Chayamachi Ladies Clinic
Osaka, 530-0013
Chayamachi ladies Clinic Hommachi
Osaka, 541-0048
Medical Corporation Koshinkai Nomura Clinic Namba
Osaka, 542-0076
Izuma Clinic
Osaka, 543-0023
Sapporo Maternity Women's Hospital
Sapporo, Hokkaido, 001-0013
Sapporo Shiroishi Obstetrics and Gynecology Hospital
Sapporo, Hokkaido, 003-0005
Hashimoto Clinic
Sapporo, Hokkaido, 004-0052
Ena Odori Clinic
Sapporo, Hokkaido, 060-0001
Sapporo Maternity Women's Minami1jo Clinic
Sapporo, Hokkaido, 060-0061
SAPPORO MEDICAL CENTER, NTT East Corporation
Sapporo, Hokkaido, 060-0061
Sapporo West Ladies Clinic
Sapporo, Hokkaido, 063-0061
Yoshio Clinic
Sapporo, Hokkaido, 064-0808
Kugayama Hospital
Setagaya-ku, Tokyo, 157-0061
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Shizuoka Saiseikai General Hospital
Shizuoka, 422-8527
Shizuoka City Shimizu Hospital
Shizuoka, 424-8636
Medical Topia Soka Hospital
Sōka, Saitama, 340-0028
Suita Municipal Hospital
Suita, Osaka, 564-0082
Asahi-Clinic
Takamatsu, Kagawa-ken, 760-0076
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557
Sato Hospital
Takasaki, Gunma, 370-0836
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, 171-0021
China32 sites
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, 100034
Beijing Tiantan Hospital, Captial Medical University
Beijing, Beijing Municipality, 100050
Beijing Hospital of Traditional Chinese Medicine
Beijing, 100010
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
Beijing, 100026
Peking Union Medical College Hospital CAMS
Beijing, 100730
The First Hospital of Jilin University
Changchun, Jilin, 130061
West China Second University Hospital
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
900th Hospital of Joint Logistics Support Force
Fuzhou, Fujian, 350025
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, 510120
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Hainan General Hospital
Haikou, Hainan, 570311
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Shandong Provincial Hospital
Jinan, Shandong, 250021
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
International Peace Maternity&Child Health Hospital of CWI
Shanghai, 200030
Changhai Hospital of Second Military Medical University
Shanghai, 200433
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
The 2nd Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50000
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30001
Tianjin Medical University General Hospital
Tianjin, 300052
First Teaching Hosptial of Tianjin University of TCM
Tianjin, 300193
Tianjin Central Hospital of Gynecology obstetrics
Tianjin, 300199
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
The Second Affliated Hospital of Wenzhou Medicial University
Wenzhou, Zhejiang, 325000
Wuhan Tongji Reproductive Medicine Hospital
Wuhan, Hubei, 430013
Russia9 sites
Scientific Center of family health & human reprod. problems
Irkutsk, 664003
Regional Clinical Hospital #2
Krasnodar, 350012
Krasnoyarsk regional perinatal center
Krasnoyarsk, 660074
City Clinical Hospital #13 Moscow
Moscow, 115280
Endocrinology Research Center
Moscow, 117036
St. Petersburg Medical University n.a. I.P. Pavlov
Saint Petersburg, 197022
Granti-Med
Saint Petersburg, 198329
Scien. Res. Institute of Obsterics, Gyn. & Reproduction
Saint Petersburg, 199034
Close Joint Stock Company "Medical Company IDK"
Samara, 443072
Czechia8 sites
Fakultní nemocnice Brno
Brno, 625 00
G-Centrum Olomouc s.r.o. Dr. Skrivanek
České Budějovice, 370 01
Fakultní Nemocnice Hradec Kralové
Hradec Králové, 500 05
MUDr. Radek Fiker s.r.o.
Jihlava, 586 01
Fakultní Nemocnice Olomouc
Olomouc, 77900
Centrum gynekologické rehabilitace, s.r.o.
Písek, Jihoceský Kraj, 397 01
Dr. Smrhova-Kovacs
Tábor, South Bohemian Region, 390 03
MUDr. Pavlina Nejedla s.r.o.
Vodňany, 389 01
Poland7 sites
Prywatna Klinika Ginekologiczno-Poloznicza
Bialystok, 15-244
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, 40-156
Vita Longa Sp. z o.o.
Katowice, 40-748
Gyncentrum Sp. z o.o.
Katowice, 40-851
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
Lodz, 90-602
Centrum Medyczne Chodzki
Lublin, 20-093
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, 20-400
South Africa7 sites
Drs AEVITAS Clinic (Pty) Ltd
Cape Town, Western Cape, 7405
University of Cape Town Clinical Research Centre
Cape Town, Western Cape, 7925
Dr L Reynders Practice
Lyttelton Manor, Gauteng, 141
Clintrials Centre for Clinical Research
Panorama, Western Cape, 7500
University of Pretoria, Clinical Research Unit
Pretoria, Gauteng, 2
Femway Inc
Umhlanga, KwaZulu-Natal, 4321
Durban International Clinical Research Site
Wentworth, KwaZulu-Natal, 4052
Turkey (Türkiye)6 sites
Cukurova Universitesi Tip Fakultesi Hastanesi
Adana, 1330
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, 6100
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast
Ankara, TBC
Uludag Universitesi Tip Fakultesi
Bursa, 16059
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, 34098
Mexico3 sites
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo León, 64460
Sanatorio Alcocer Pozo S. A. de C. V.
Querétaro, 76000
Centro Integral Médico de San Juan del Río S. C.
San Juan del Río, Querétaro, 76800
Norway3 sites
Kirkeparken Spesialistpraksis
Fredrikstad, 1605
Nesttun Spesialistpraksis AS
Nesttun, 5221
Medicus AS
Trondheim, 7014
Finland2 sites
Mehilainen | Mehilainen Kuopio
Kuopio, 70100
Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland
Oulu, 90100
Thailand2 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Siriraj Hospital, Mahidol
Bangkok, 10700
About this study
Official title: An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Versus Standard of Care
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
- Conditions
- Uterine Fibroids
- Being tested
- Vilaprisan (BAY1002670), Standard of care
- Keywords
- Uterine Fibroid
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilaprisan (BAY1002670)Drug
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).
Vilaprisan (BAY1002670)Drug
2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).
Vilaprisan (BAY1002670)Drug
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).
Standard of careOther
Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)
Vilaprisan (BAY1002670)Drug
2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
Vilaprisan (BAY1002670)Drug
2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen)
Vilaprisan (BAY1002670)Drug
2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
| Study group | Role | What they receive |
|---|---|---|
| A1(3/1 regimen) | Experimental | 2.0 mg treatment of 12 weeks, each separated by 1 bleeding break Receives: Drug: Vilaprisan (BAY1002670) |
| A2(6/2 regimen) | Experimental | 2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break Receives: Drug: Vilaprisan (BAY1002670) |
| A3(3/2 regimen) | Experimental | 2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break Receives: Drug: Vilaprisan (BAY1002670) |
| B(Standard of care) | Other | Standard of care as determined by the investigators, this could be watch \& wait or non-hormonal medical treatment Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine
The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.
Measured: From baseline to about 1 year after start of treatment
Secondary outcomes (4)
Number of Bleeding Days
Number of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days
Measured: Treatment phase: approximately 1 year
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy
Measured: Up to 3 years (from study treatment start to end of study)
Change From Baseline in Endometrial Thickness
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table.
Measured: Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.
Measured: Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start30 Jun 2017
- Primary completion10 May 2019
- Study completion11 Jul 2024
Why it stopped: Due to a change in the development program, the study was closed prematurely.
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.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 1,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194646
- Sponsor's protocol ID
- 16953
- Other IDs
- 2016-004822-41, 2016
- Acronym
- ASTEROID 6
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2017
- Last updated
- 28 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.