Drug-Related Side Effects and Adverse ReactionsPhase 1PRIMENCT03098680
A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
A Phase 1 study testing Albuterol Sulfate, Nicardipine Hydrochloride and Dobutamine Hydrochloride in people with Drug-Related Side Effects and Adverse Reactions and Cardiovascular System Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Unwanted effects on the cardiovascular system is one of the most common causes of safety related discontinuation of a drug. This study aims to develop an in silico model of the human cardiovascular system that can be used to predict unwanted cardiovascular effects of drugs. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug-Related Side Effects and Adverse Reactions, Cardiovascular System Disease
- What is being tested?
- Albuterol Sulfate, Nicardipine Hydrochloride and Dobutamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2017to 29 Feb 2020
- Phase
- Phase 1
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The presence of any of the following will preclude patient inclusion:
- Less than 18 years old, >30 years old
- BMI >30
- On regular medications
- Known allergy to medications
- History of psychiatric, chronic cardiac / respiratory / renal disease
Show all 49Show fewer
- Known diagnosis of diabetes
- Habitual smoker
- Screening heart rate of less than 60 beats per minute
- Screening heart rate of greater than 100 beats per minute
- Screening blood pressure of less than 100mmHg systolic and/or 55mmHg diastolic
- Any concomitant condition or circumstance that, at the discretion of the investigator, may affect the participant's ability to complete the study
- Current participation in another interventional research study
- Part B Inclusion Criteria
- To be included in the study the patient must:
- Have given written informed consent to participate
- Male
- Be aged over 18 years at the time of first study appointment
- Possess one of the following - known diagnosis of diabetes, known diagnosis of hypertension, obesity (BMI>30), aged >65
- Deemed healthy to partake in the study at the discretion of the investigator
- The presence of any of the following will preclude patient inclusion:
- Less than 18 years old
- On regular medications that are contraindicated for co-use with the study drugs
- Known allergy to medications
- Screening heart rate of less than 60 beats per minute
- Screening heart rate of greater than 100 beats per minute
- Screening blood pressure of less than 100mmHg systolic and/or 55mmHg diastolic
- Any concomitant condition or circumstance that, at the discretion of the investigator, may affect the participant's ability to complete the study
- Current participation in another interventional research study
- Part C Inclusion Criteria
- To be included in the study the patient must:
- Have given written informed consent to participate
- Male
- Be aged over 18 years at the time of first study appointment
- Clinical diagnosis of autonomic dysfunction
- BMI<30
- Deemed healthy to partake in the study at the discretion of the investigator
- The presence of any of the following will preclude patient inclusion:
- Less than 18 years old
- BMI >30
- On regular medication
- Known allergy to medications
- History of psychiatric, chronic cardiac / respiratory / renal disease
- Habitual smoker
- Screening heart rate of less than 60 beats per minute
- Screening heart rate of greater than 100 beats per minute
- Screening blood pressure of less than 100mmHg systolic and/or 55mmHg diastolic
- Any concomitant condition or circumstance that, at the discretion of the investigator, may affect the participant's ability to complete the study
- Current participation in another interventional research study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Unwanted effects on the cardiovascular system is one of the most common causes of safety related discontinuation of a drug. This study aims to develop an in silico model of the human cardiovascular system that can be used to predict unwanted cardiovascular effects of drugs. This will be achieved through a drug administration study that will generate comprehensive pharmacokinetic and pharmacodynamic data following the administration of the following drugs, all known to have effects on the cardiovascular system. Half the participants will receive: Placebo, Salbutamol, Nicardipine, Dobutamine and the other half will receive Placebo, Phenylephrine, Verapamil, Phentolamine.
Read the detailed description
Safety is an integral part of developing new medicines. Potential drugs can be withdrawn from development at any stage of the process if there are concerns over safety. In recent years, computer models that recreate physiology have been increasingly adopted in various aspects of drug development, including safety, to predict the effects of new drugs. The accuracy of this predictive model is however, dependent on the ability for animal data (which the model is usually based on) to be 'translated' to human data. As no animal is identical to humans, the difference between species needs to be understood for the model to be accurate.
Unwanted effects on the cardiovascular system is one of the most common causes of safety related discontinuation of a drug. The present study focuses on generating high quality human cardiovascular data that is comparable with existing animal data. This will be achieved through the collection of detailed pharmacokinetic and pharmacodynamic data following administration of drugs that are known to affect the cardiovascular system through a range of mechanisms. This will be first performed in healthy participants before extending it to those with pre-existing (or risk-factors for) cardiovascular disease. The aim is to understand the differences between species and the study populations and using the collected data to help inform how a translational model is to be built.
Study Design: Single centre, single (participant) blind, within subject, drug administration study
Drugs used in study:
- Salbutamol - a beta-2-adrenergic agonist
- Nicardipine - a dihydropyridine calcium channel antagonist
- Dobutamine - a beta-1-adrenergic agonist
- Phenylephrine - a selective alpha-1-adrenergic agonist
- Verapamil - a phenylalkylamine calcium channel antagonist
- Phentolamine - a non-selective alpha adrenergic antagonist
Study Population:
The study will take place in three parts (A, B and C), with each part representing population groups that are of interest.
Part A (16 participants): Healthy individuals with no identifiable cardiovascular risk factors will be recruited for this part of the study. The aim of this part is to enable the collection of physiological data after drug administration in a 'normal' cardiovascular system.
Part B (8 participants): Part B will involve the recruitment of participants who may possess an altered/challenged cardiovascular system. Participants recruited will possess one of the following factors: known diagnosis of diabetes, known diagnosis of hypertension, obesity (BMI>30), age >65. The data collected will provide information on how potential changes to baseline cardiovascular physiology may affect the effect of the drug.
Part C (8 participants): In order to understand the impact of medicines on cardiovascular physiology in the absence of the autonomic nervous system regulation, we will recruit participants with dysfunction of the autonomic system to Part C of the study.
Maximum duration of participation for each participant:
1x screening (1 hour duration), 4x study visits (8 hour duration each) with minimum 72 hours gap in between visits. Maximum duration is 4 months to complete all visits.
- Being tested
- Albuterol Sulfate, Nicardipine Hydrochloride, Dobutamine Hydrochloride, Phenylephrine Hydrochloride, Verapamil Hydrochloride
- Keywords
- Adverse reactions, Cardiovascular, Translation, Modelling, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol SulfateDrug
Also called Salbutamol Sulfate
see arm/group descriptions
Nicardipine HydrochlorideDrug
see arm/group descriptions
Dobutamine HydrochlorideDrug
see arm/group descriptions
Phenylephrine HydrochlorideDrug
see arm/group descriptions
Verapamil HydrochlorideDrug
Also called Securon IV
see arm/group descriptions
Phentolamine MesylateDrug
Also called Phentolamine Mesilate
see arm/group descriptions
PlaceboDrug
Also called 0.9% Sodium Chloride
see arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Group A (Placebo, Salbutamol, Nicardipine, Dobutamine) | Experimental | Participants will receive each drug, to be given on separate study days. The drugs will be given as a 3 stage infusion with dose increasing at each stage. Each stage will be 30 minutes in duration.
Placebo; Salbutamol(Albuterol) Sulfate (Dose: 2mcg/min, 5mcg/min, 10mcg/min); Nicardipine Hydrochloride (Dose: 1mg/hr, 2.5mg/hr, 5mg/hr); Dobutamine Hydrochloride (Dose: 1mcg/kg/min, 2.5mcg/kg/min, 5mcg/kg/min) Receives: Drug: Albuterol Sulfate; Drug: Nicardipine Hydrochloride; Drug: Dobutamine Hydrochloride; Drug: Placebo |
| Group B (Placebo, Phenylephrine, Verapamil, Phentolamine) | Experimental | Participants will receive each drug, to be given on separate study days. The drugs will be given as a 3 stage bolus with dose increasing at each stage. Each stage will be 30 minutes apart.
Placebo; Phenylephrine Hydrochloride (Dose: 100mcg, 200mcg, 300mcg); Verapamil Hydrochloride (Dose: 1mg, 2.5mg, 5mg); Phentolamine Mesylate (Dose: 1mg, 2mg, 3mg) Receives: Drug: Phenylephrine Hydrochloride; Drug: Verapamil Hydrochloride; Drug: Phentolamine Mesylate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Change in heart rate from baseline over time after administration of drug
Measured: At every study visit (each lasting up to 8 hours)
Peripheral blood pressure
Change in resting peripheral blood pressure (systolic, diastolic, pulse pressure and mean pressure) over time after administration of drug
Measured: At every study visit (each lasting up to 8 hours)
Central blood pressure
Change in resting central aortic pressure (systolic, diastolic, pulse pressure and mean pressure) from baseline over time after administration of drug
Measured: At every study visit (each lasting up to 8 hours)
Cardiac output
Change in cardiac output from baseline over time after administration of drug
Measured: At every study visit (each lasting up to 8 hours)
Stroke volume
Change in stroke volume from baseline over time after administration of drug
Measured: At every study visit (each lasting up to 8 hours)
ECG/Cardiac monitor
Change in ECG (PR interval/QRS interval/QT interval/QTc interval/RR interval) over time after administration of drug
Measured: At every study visit (each lasting up to 8 hours)
Secondary outcomes (4)
Plasma drug concentration (all drugs)
Measure of drug levels (parent compound and active metabolites) at the specified time points
Measured: These will be measured during each part of the study, estimated 6 months per part. Taken at: -(5mins, 10mins,15mins, 30mins, 35mins, 40mins, 45mins, 60mins, 65mins, 70mins, 75mins, 90mins, 120mins, 150mins, 180mins, 240mins, 360mins)
Plasma drug (active) metabolite concentration (varapamil only)
Measure of drug levels (parent compound and active metabolites) at the specified time points
Measured: Throughout the study, estimated 6 months per part. Taken at specified timepoints (5mins, 10min, 15mins, 30mins, 35mins, 40mins, 45mins, 60mins, 65mins, 70mins, 75mins, 90mins, 120mins, 150mins, 180mins, 240mins, 360mins)
Renal Function
Changes in renal function throughout study
Measured: Through study completion, up to 4 months
Liver function
Changes in liver function throughout study
Measured: Through study completion, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start24 Apr 2017
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Why it stopped: Unable to recruit in time before end of PhD studentship
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Related Side Effects and Adverse ReactionsStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, AstraZeneca
- Responsible party
- Principal investigator, Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Joseph Cheriyan, MBCHB, MA, FRCP, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098680
- Sponsor's protocol ID
- PRIME (A094136)
- Acronym
- PRIME
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2017
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
- ClinicalTrials.gov ID
- NCT03098680
- Acronym / sponsor ID
- PRIME / PRIME (A094136)
- Keywords
- Adverse reactions, Cardiovascular, Translation, Modelling, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit in time before end of PhD studentship
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, AstraZeneca
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 4 Apr 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.
Unwanted effects on the cardiovascular system is one of the most common causes of safety related discontinuation of a drug. This study aims to develop an in silico model of the human cardiovascular system that can be used to predict unwanted cardiovascular effects of drugs. This will be achieved through a drug administration study that will generate comprehensive pharmacokinetic and pharmacodynamic data following the administration of the following drugs, all known to have effects on the cardiovascular system. Half the participants will receive: Placebo, Salbutamol, Nicardipine, Dobutamine and the other half will receive Placebo, Phenylephrine, Verapamil, Phentolamine.
Detailed description
Safety is an integral part of developing new medicines. Potential drugs can be withdrawn from development at any stage of the process if there are concerns over safety. In recent years, computer models that recreate physiology have been increasingly adopted in various aspects of drug development, including safety, to predict the effects of new drugs. The accuracy of this predictive model is however, dependent on the ability for animal data (which the model is usually based on) to be 'translated' to human data. As no animal is identical to humans, the difference between species needs to be understood for the model to be accurate.
Unwanted effects on the cardiovascular system is one of the most common causes of safety related discontinuation of a drug. The present study focuses on generating high quality human cardiovascular data that is comparable with existing animal data. This will be achieved through the collection of detailed pharmacokinetic and pharmacodynamic data following administration of drugs that are known to affect the cardiovascular system through a range of mechanisms. This will be first performed in healthy participants before extending it to those with pre-existing (or risk-factors for) cardiovascular disease. The aim is to understand the differences between species and the study populations and using the collected data to help inform how a translational model is to be built.
Study Design: Single centre, single (participant) blind, within subject, drug administration study
Drugs used in study:
- Salbutamol - a beta-2-adrenergic agonist
- Nicardipine - a dihydropyridine calcium channel antagonist
- Dobutamine - a beta-1-adrenergic agonist
- Phenylephrine - a selective alpha-1-adrenergic agonist
- Verapamil - a phenylalkylamine calcium channel antagonist
- Phentolamine - a non-selective alpha adrenergic antagonist
Study Population:
The study will take place in three parts (A, B and C), with each part representing population groups that are of interest.
Part A (16 participants): Healthy individuals with no identifiable cardiovascular risk factors will be recruited for this part of the study. The aim of this part is to enable the collection of physiological data after drug administration in a 'normal' cardiovascular system.
Part B (8 participants): Part B will involve the recruitment of participants who may possess an altered/challenged cardiovascular system. Participants recruited will possess one of the following factors: known diagnosis of diabetes, known diagnosis of hypertension, obesity (BMI>30), age >65. The data collected will provide information on how potential changes to baseline cardiovascular physiology may affect the effect of the drug.
Part C (8 participants): In order to understand the impact of medicines on cardiovascular physiology in the absence of the autonomic nervous system regulation, we will recruit participants with dysfunction of the autonomic system to Part C of the study.
Maximum duration of participation for each participant:
1x screening (1 hour duration), 4x study visits (8 hour duration each) with minimum 72 hours gap in between visits. Maximum duration is 4 months to complete all visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Placebo, Salbutamol, Nicardipine, Dobutamine) | Experimental | Drug: Albuterol Sulfate, Drug: Nicardipine Hydrochloride, Drug: Dobutamine Hydrochloride, Drug: PlaceboParticipants will receive each drug, to be given on separate study days. The drugs will be given as a 3 stage infusion with dose increasing at each stage. Each stage will be 30 minutes in duration. Placebo; Salbutamol(Albuterol) Sulfate (Dose: 2mcg/min, 5mcg/min, 10mcg/min); Nicardipine Hydrochloride (Dose: 1mg/hr, 2.5mg/hr, 5mg/hr); Dobutamine Hydrochloride (Dose: 1mcg/kg/min, 2.5mcg/kg/min, 5mcg/kg/min) |
| Group B (Placebo, Phenylephrine, Verapamil, Phentolamine) | Experimental | Drug: Phenylephrine Hydrochloride, Drug: Verapamil Hydrochloride, Drug: Phentolamine Mesylate, Drug: PlaceboParticipants will receive each drug, to be given on separate study days. The drugs will be given as a 3 stage bolus with dose increasing at each stage. Each stage will be 30 minutes apart. Placebo; Phenylephrine Hydrochloride (Dose: 100mcg, 200mcg, 300mcg); Verapamil Hydrochloride (Dose: 1mg, 2.5mg, 5mg); Phentolamine Mesylate (Dose: 1mg, 2mg, 3mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (49 listed)
- Less than 18 years old, >30 years old
- BMI >30
- On regular medications
- Known allergy to medications
- History of psychiatric, chronic cardiac / respiratory / renal disease
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 |
|---|---|---|
| Albuterol SulfateAlso: Salbutamol Sulfatesee arm/group descriptions | Drug | Group A (Placebo, Salbutamol, Nicardipine, Dobutamine) |
| Nicardipine Hydrochloridesee arm/group descriptions | Drug | Group A (Placebo, Salbutamol, Nicardipine, Dobutamine) |
| Dobutamine Hydrochloridesee arm/group descriptions | Drug | Group A (Placebo, Salbutamol, Nicardipine, Dobutamine) |
| Phenylephrine Hydrochloridesee arm/group descriptions | Drug | Group B (Placebo, Phenylephrine, Verapamil, Phentolamine) |
| Verapamil HydrochlorideAlso: Securon IVsee arm/group descriptions | Drug | Group B (Placebo, Phenylephrine, Verapamil, Phentolamine) |
| Phentolamine MesylateAlso: Phentolamine Mesilatesee arm/group descriptions | Drug | Group B (Placebo, Phenylephrine, Verapamil, Phentolamine) |
| PlaceboAlso: 0.9% Sodium Chloridesee arm/group descriptions | Drug | Group A (Placebo, Salbutamol, Nicardipine, Dobutamine), Group B (Placebo, Phenylephrine, Verapamil, Phentolamine) |
Primary outcome
Heart rate
Time frame: At every study visit (each lasting up to 8 hours)
Change in heart rate from baseline over time after administration of drug
Peripheral blood pressure
Time frame: At every study visit (each lasting up to 8 hours)
Change in resting peripheral blood pressure (systolic, diastolic, pulse pressure and mean pressure) over time after administration of drug
Central blood pressure
Time frame: At every study visit (each lasting up to 8 hours)
Change in resting central aortic pressure (systolic, diastolic, pulse pressure and mean pressure) from baseline over time after administration of drug
Cardiac output
Time frame: At every study visit (each lasting up to 8 hours)
Change in cardiac output from baseline over time after administration of drug
Stroke volume
Time frame: At every study visit (each lasting up to 8 hours)
Change in stroke volume from baseline over time after administration of drug
ECG/Cardiac monitor
Time frame: At every study visit (each lasting up to 8 hours)
Change in ECG (PR interval/QRS interval/QT interval/QTc interval/RR interval) over time after administration of drug
4 secondary outcomes
Plasma drug concentration (all drugs)
Time frame: These will be measured during each part of the study, estimated 6 months per part. Taken at: -(5mins, 10mins,15mins, 30mins, 35mins, 40mins, 45mins, 60mins, 65mins, 70mins, 75mins, 90mins, 120mins, 150mins, 180mins, 240mins, 360mins)
Plasma drug (active) metabolite concentration (varapamil only)
Time frame: Throughout the study, estimated 6 months per part. Taken at specified timepoints (5mins, 10min, 15mins, 30mins, 35mins, 40mins, 45mins, 60mins, 65mins, 70mins, 75mins, 90mins, 120mins, 150mins, 180mins, 240mins, 360mins)
Renal Function
Time frame: Through study completion, up to 4 months
Liver function
Time frame: Through study completion, up to 4 months
Results and safety
The study was stopped early (reason given: Unable to recruit in time before end of PhD studentship). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- 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.
Joseph Cheriyan, MBCHB, MA, FRCP principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Albuterol Sulfate, Nicardipine Hydrochloride and Dobutamine Hydrochloride in people with Drug-Related Side Effects and Adverse Reactions and Cardiovascular System Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 0 inclusion and 49 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: stopped early, as of the sponsor's last update on 22 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 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit in time before end of PhD studentship). Results are not available in the source record.
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?
Heart rate (time frame: At every study visit (each lasting up to 8 hours)). The study lists 6 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 22 Mar 2021.