DiabetesPhase 3NCT03254446
Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension
A Phase 3 study testing TRC150094 in people with Diabetes and Dyslipidemias, run by Torrent Pharmaceuticals Limited at 21 sites in 3 countries.
Trial summary
The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes, Dyslipidemias, Hypertension
- What is being tested?
- TRC150094
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,250 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 12 Mar 2018to Aug 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects in the age range 30-70 years (both inclusive)
- BMI in the range 23-39 (inclusive) kg/m2
- HbA1C ≥7.5 %
- Stable therapy of ≤2 oral hypoglycemic agents for at least two months prior to screening at doses that are appropriate for the duration of the study in the judgment of the investigator.
- Non HDL-cholesterol ≥ 160 mg/dL.
- Mean Arterial Pressure (MAP) ≥100 mm Hg based on average of 24 hours' ambulatory blood pressure monitoring (ABPM) with or without antihypertensive treatment (subjects will have to be on stable dose of anti-hypertensive treatment for at least two months prior to screening); Dose should be appropriate for the duration of the study in the judgment of the investigator.
- Willing to give written informed consent
- Ability to adhere to the study restrictions and assessments schedule
Who cannot join
- Uncontrolled hypertension: SBP of ≥ 180 mm Hg and DBP ≥ 110 mmHg based on average of 24 hours' ambulatory blood pressure monitoring.
- HbA1C > 10 % at screening.
- Serum triglycerides >400 mg/dL.
- LDL-cholesterol >300 mg/dL or medical history/clinical evidence of familial hyperlipidemic disorder.
- Subjects on Insulin or Sodium Glucose Co-Transporter 2 (SGLT2) inhibitors.
- Acute coronary syndrome (ACS) or stroke or any revascularization within last 6 months.
Show all 17Show fewer
- Subjects having untreated thyroid dysfunction (TSH <0.3 or >5.5 µIU/mL) or hormone related obesity disorder.
- Subjects with liver enzymes (SGOT, SGPT) more than 3X of upper limit of normal value.
- eGFR <30 mL/min as evaluated by Modification of Diet in Renal Disease (MDRD) method.
- Seropositive for HIV, Hepatitis B or Hepatitis C.
- History of alcohol or drug abuse, psychiatric disorder, any bleeding disorder, malignancy in last 3 years.
- Pregnant or lactating women.
- Female of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (double barrier methods or intrauterine device).
- Male subjects with partners of childbearing potential not willing to use reliable contraception methods.
- Clinically significant abnormal physical findings, laboratory results, ECG findings and/or any other clinical observation or history during the screening examination, which would interfere with the objectives of the study.
- Intake of any investigational drug within 3 months prior to the first dose of study drug.
- In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or plan to relocate during the study.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
India12 sites, 12 recruiting
- Recruiting
Bangalore Diabetes Centre, No. 426, 4th Cross, 2nd block, kalyan nagar,
Bangalore, Karnataka, 560043
Paramesh Shamanna, MBBS, MD, 9845010610, drparamesh2@gmail.com
Dr. Ambrish Chandrappa, MBBS, MD, 9845895911, ambidrcool@gmail.com
- Recruiting
Government Medical College, Government Medical College Campus,
Calicut, Kerala, 673008
Neeraj Manikath, MBBS, DNB, 9447391055, nmanikath@gmail.com
Dr.Chyandni R., MBBS,MD,PHD
- Recruiting
Apollo Hospitals, PR No. 3-5-836 to 838, Near Old MLA Quarters,
Hyderabad, Telangana, 500029
Harikishan Boorugu, M.B.B.S.M.D., 9642767757, drharikishan@gmail.com
Dr.Arshad Pujani, M.B.B.S., 9866081267, arpunjani@gmail.com
- Recruiting
S.R Kalla Memorial Gastro and General Hospital
Jaipur, Rajasthan, 302001
Dr. Nikhil Parikh, MBBS,MD,DM, 9829054944, drnikhilpareek@gmail.com
Dr. Rajiv Tiwari, MBBS, MD, +91-141-5112042, drrajeevtiwari@rediffmail.com
- Recruiting
Diabetes ,Thyroid and Endocrine Centre
Jaipur, Rajasthan, 302006
Surendra K Sharma, MBBS.MD,DM, 9829010233, sksharmacr@gmail.com
Sheela Sharma, MBBS.MD, +91 1412451946, sheelasharmacr2016@gmail.com
- Recruiting
Lisie Hospital
Kochi, Kerala, 682017
Paulose George, MBBS, MD, 9895021667, geepee44@yahoo.com
Jabir Abdullakutty, MBBS, DM, 9447011773, drjabi@yahoo.co.in
- Recruiting
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
Parminder Singh, MBBS, MD, DM, 9814077536, pam.endo@yahoo.co.in;
damandeep P Kaur, 9814066999
- Recruiting
Supe Heart and Diabetes Hospital and Research Centre,
Nashik, Maharashtra, 422002
PRAVIN SUPE, M.D., +91-253-2232487, pravinsupe@ymail.com
ANUPAMA SUPE, M.B.B.S, +91-253-2232487, pravinsupe@ymail.com
- Recruiting
Medipoint Hospitals Pvt. Ltd
Pune, Maharashtra, 411007,
Girish Bhatia, MD, +917387003636, drbhatia.pentagon@gmail.com
Shailaja G Bhatia, MBBS,MD, +919527016688
- Recruiting
BAPS Pramukh Swami Hospital,
Surat, Gujarat, 395009
Dr. Parshottam Koradia, MBBS, MD, 9825312027, purushottam_koradia@yahoo.co.in
Dr. Anand Modi, DNB, 9825312027, purushottam_koradia@yahoo.co.in
- Recruiting
Indian Institute of Diabetes
Thiruvananthapuram, Kerala, 695031
Jabbar P, MBBS, MD, 0471-2559388, iidtvm@yahoo.com
Abhilash Nair, MBBS,MD, 9495378383, abhimck@gmail.com
- Recruiting
Ashirwad Hospital & Research Centre
Ulhasnagar, Maharashtra, 421004
Shrikant Deshpande, MBBS, MD, 9822017445, writetoshrikant@rediffmail.com
R. M. Mundada, MBBS,MD, 9822676212, drrm03@gmail.com
Brazil5 sites, 5 recruiting
- Recruiting
Av. Farroupilha, 8001 Prédio 21, Recepção C, Bairro São José - Canoas/RS
Canoas
Cristiano P Jaeger, cardiologist, 55 51 3478-8152, cristianojaeger@hotmail.com
Patricia E Pizzato, Cardiologist, 55 51 3478-8152, patipizzato@hotmail.com
- Recruiting
Comitê de ética em Pesquisa do Hospital Pró Cardíaco
Rio de Janeiro, Botafogo, 22270-005
Luis Augusto Russo, MD PhD, MBA, 55 21 99988 0336
Joselita S Bodart, MD, Physian, 55 21 986961073
- Recruiting
Rua Silva Jardim
São Bernardo do Campo, São Paulo, 09715-090 -
Claudia M de Brito, MD, Physian, 55 11 95369-9341
Andrea S Audi, MD, Physian, 55 11 95369-9341
- Recruiting
Avenida Angélica
São Paulo, CEP, 01228-200
Freddy G Eliaschewitz, Endocrino, 55 11 27110298, freddy.g@uol.com.br
Denise R Franco, Endocrino, 55 11 27110298, d9franco@gmail.com
- Recruiting
Rua Coronel Aureliano de Camargo,905, Centro,
Tatuí
Wladmir F Saporito, Cardiologist, 55 15 3451-1300, wfsaporito@uol.com.br
Roberto S Almeida, cardiologist, 55 15 3451-1300 ext. 219, robertocardiologia@hotmail.com
Philippines4 sites, 4 recruiting
- Recruiting
Angeles University Foundation Medical Center
Angeles City, Pampanga, 2009
Dr. Gabriel Jocson, Cardiologist, jocsongabriel@gmail.com
Rose A Barranda, Coordinator, roseann.barranda@yahoo.com
- Recruiting
De La Salle Heath Sciences Institute
Dasmariñas, Cavite, 4114
Dr. Olivia P Roderos, Endocrlogist, oliveproderos@gmail.com
Wendy Cudiamat, wcudiamat74@gmail.com
- Recruiting
Davao Doctors Hospital
Davao City, 8000
Aquitania Grace, Int.Med
Emily R Doliente, Int.Med
- Recruiting
St. Paul's Hospital
General Luna, Saint Iloilo City, 5000
Ygpuara M Lallaine, Int.Med
Dr. Efren E Jr, Int.Med, efrenestocejr@yahoo.com
About this study
Official title: A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study to Evaluate Efficacy and Safety of TRC150094 as an Add On to Standard of Care in Improving Cardiovascular Risk in Subjects With Diabetes, Dyslipidemia and Hypertension
The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.
Read the detailed description
TRC150094 is an Investigational Product for the treatment of CV risk associated with non-traditional risk factors ie, diabetes, hypertension and dyslipidemia, which acts by increasing the energy expenditure and restoring mitochondrial flexibility which is deranged in patients with these risk factors. Treatment with TRC150094 has shown clinically meaningful benefits in well-established contributors of CV risk i.e., insulin resistance and hyperglycemia, SBP as well as non-traditional risk factors i.e. non-HDL cholesterol and MAP, over and above standard of care.
The phase III trial is designed with an aim of determining the efficacy of TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.
Primary Objective of the study is, To evaluate the efficacy of TRC150094 in improving cardiovascular (CV) risk in subjects with diabetes, dyslipidemia and hypertension Secondary Objectives of the study are,
- To evaluate safety of TRC150094 in subjects with diabetes, dyslipidemia and hypertension
- To evaluate extended safety profile of TRC150094 beyond 24 weeks of treatment in subjects with diabetes, dyslipidemia and hypertension
In this study there will be five visits at week 4, 12, 24, 36 and 50 after enrolment.
- Conditions
- Diabetes, Dyslipidemias, Hypertension
- Being tested
- TRC150094, Placebo
- Keywords
- Diabetes, Hypertension, Dyslipidemia, Cardiovascular Risk
- Medical subject headings
- Diabetes Mellitus, Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRC150094Drug
TRC150094 Tablet 45 mg
PlaceboDrug
Matching Placebo Tablet
| Study group | Role | What they receive |
|---|---|---|
| TRC150094 45 mg | Experimental | TRC150094 45 mg Tablet to be administered orally once a day for 50 weeks Receives: Drug: TRC150094 |
| Placebo | Placebo comparator | Matching Placebo Tablet to be administered orally once a day for 50 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c
Mean change in weighted average composite score of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks of treatment between arms
Measured: 24 Weeks
Change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score
Mean change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score at the end of 24 weeks of treatment between arms
Measured: 24 Weeks
Secondary outcomes (3)
Change in MAP
Mean change in MAP from baseline to 24 weeks of treatment
Measured: 24 Weeks
Change in non-HDL cholesterol
Mean change in non-HDL cholesterol from baseline to 24 weeks of treatment
Measured: 24 Weeks
Change in HbA1c
Mean change in HbA1c from baseline to 24 weeks of treatment
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start12 Mar 2018
- Primary completionApr 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Model description
- Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Nikhil Tandon, M.D., PhD, Study chair, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254446
- Sponsor's protocol ID
- CT/P015/CMR/16/03_01
- Status last verified
- Jul 2020
- First submitted
- 16 Aug 2017
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study to Evaluate Efficacy and Safety of TRC150094 as an Add On to Standard of Care in Improving Cardiovascular Risk in Subjects With Diabetes, Dyslipidemia and Hypertension
- ClinicalTrials.gov ID
- NCT03254446
- Acronym / sponsor ID
- CT/P015/CMR/16/03_01
- Conditions
- Diabetes, Dyslipidemias, Hypertension
- Keywords
- Diabetes, Hypertension, Dyslipidemia, Cardiovascular Risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.
Detailed description
TRC150094 is an Investigational Product for the treatment of CV risk associated with non-traditional risk factors ie, diabetes, hypertension and dyslipidemia, which acts by increasing the energy expenditure and restoring mitochondrial flexibility which is deranged in patients with these risk factors. Treatment with TRC150094 has shown clinically meaningful benefits in well-established contributors of CV risk i.e., insulin resistance and hyperglycemia, SBP as well as non-traditional risk factors i.e. non-HDL cholesterol and MAP, over and above standard of care.
The phase III trial is designed with an aim of determining the efficacy of TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.
Primary Objective of the study is, To evaluate the efficacy of TRC150094 in improving cardiovascular (CV) risk in subjects with diabetes, dyslipidemia and hypertension Secondary Objectives of the study are,
- To evaluate safety of TRC150094 in subjects with diabetes, dyslipidemia and hypertension
- To evaluate extended safety profile of TRC150094 beyond 24 weeks of treatment in subjects with diabetes, dyslipidemia and hypertension
In this study there will be five visits at week 4, 12, 24, 36 and 50 after enrolment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study
| Arm | Type | Receives |
|---|---|---|
| TRC150094 45 mg | Experimental | Drug: TRC150094TRC150094 45 mg Tablet to be administered orally once a day for 50 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo Tablet to be administered orally once a day for 50 weeks |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects in the age range 30-70 years (both inclusive)
- BMI in the range 23-39 (inclusive) kg/m2
- HbA1C ≥7.5 %
- Stable therapy of ≤2 oral hypoglycemic agents for at least two months prior to screening at doses that are appropriate for the duration of the study in the judgment of the investigator.
- Non HDL-cholesterol ≥ 160 mg/dL.
Key exclusion criteria (17 listed)
- Uncontrolled hypertension: SBP of ≥ 180 mm Hg and DBP ≥ 110 mmHg based on average of 24 hours' ambulatory blood pressure monitoring.
- HbA1C > 10 % at screening.
- Serum triglycerides >400 mg/dL.
- LDL-cholesterol >300 mg/dL or medical history/clinical evidence of familial hyperlipidemic disorder.
- Subjects on Insulin or Sodium Glucose Co-Transporter 2 (SGLT2) inhibitors.
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 |
|---|---|---|
| TRC150094TRC150094 Tablet 45 mg | Drug | TRC150094 45 mg |
| PlaceboMatching Placebo Tablet | Drug | Placebo |
Primary outcome
Change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c
Time frame: 24 Weeks
Mean change in weighted average composite score of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks of treatment between arms
Change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score
Time frame: 24 Weeks
Mean change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score at the end of 24 weeks of treatment between arms
3 secondary outcomes
Change in MAP
Time frame: 24 Weeks
Change in non-HDL cholesterol
Time frame: 24 Weeks
Change in HbA1c
Time frame: 24 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Nikhil Tandon, M.D., PhD study chair
All India Institute of Medical Sciences
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TRC150094 in people with Diabetes and Dyslipidemias, run by Torrent Pharmaceuticals Limited at 21 sites in 3 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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in India, Brazil, Philippines. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shohini Ghosh, PhD (+91-79-23969100 ext. 574, shohinighosh@torrentpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c (time frame: 24 Weeks). 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?
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 17 Jul 2020.