Atrial FibrillationPhase 1CADENCE 215NCT01483183
Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation
A Phase 1 study testing OPC-108459 in people with Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 25 sites in 6 countries.
Trial summary
The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF). The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of OPC-108459 for the treatment of paroxysmal and persistent atrial… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- OPC-108459
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 25 sitesin 6 countries
- Study dates
- Nov 2011to Oct 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with paroxysmal atrial fibrillation (AF) (recent or new onset) or subjects with persistent AF at the time of randomization
- Subjects who are hemodynamically stable
- Subjects with a low risk of thromboembolic potential
- Subjects who are willing to comply with the reproductive precautions
Who cannot join
- Subjects with:
- History of long QT syndrome, Torsade de Pointes or an uncorrected QT interval of > 450 ms
- History of myocardial infarction within 6 months of screening
- Acute coronary syndrome, angina or active myocardial ischemia diagnosed by ECG, or other imaging within 6 months of screening
- History of ventricular tachycardia, fibrillation, or resuscitated cardiac arrest
- History of clinically significant congenital heart disease
Show all 19Show fewer
- Presence of severe aortic or mitral stenosis, aortic or mitral regurgitation, atrial septal defect, or other conditions leading to AF
- Diagnosis of heart failure NYHA Class II-IV or with an ejection fraction <40% (Part 1 only)
- Diagnosis of heart failure NYHA Class IV or NYHA I, II, or III with an ejection fraction <35% (Part 2 only)
- Concomitant treatment with class I or III anti-arrhythmics agents unless the medication was discontinued more than 5 half-lives before dosing
- History of seizures
- Diagnosis of atrial flutter
- Diagnosis of stroke, TIA (transient ischemic attack), or any transient neurological deficit within 1 year of screening or known carotid artery stenosis of >50%
- Cardiac surgery within 3 months of screening
- Bradycardia (< 50 bpm) or sick sinus syndrome, unless controlled by a pacemaker
- Current reversible cause of AF
- Wolff-Parkinson-White syndrome
- Any congenital abnormality, severe valve disease
- Subjects who have taken another investigational product within 30 days of dosing
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
United States9 sites
Otsuka Investigational Site
Germantown, Tennessee, 38138
Otsuka Investigational Site
Hollywood, Florida, 33021
Otsuka Investigational Site
Houston, Texas, 77024
Otsuka Investigational Site
Jacksonville, Florida, 32209
Otsuka Investigational Site
Johnson City, New York, 13790
Otsuka Investigational Site
Lexington, Kentucky, 40536
Otsuka Investigational Site
New Orleans, Louisiana, 70112
Otsuka Investigational Site
Sarasota, Florida, 34232
Otsuka Investigational Site
Washington D.C., District of Columbia, 20422
Spain5 sites
Otsuka Investigational Site
Barcelona, 08970
Otsuka Investigational Site
Fuenlabrada, Madrid, 28942
Otsuka Investigational Site
Granada, 18014
Otsuka Investigational Site
Madrid, 28034
Otsuka Investigational Site
Madrid, 28905
Germany4 sites
Otsuka Investigational Site
Berlin, 13953
Otsuka Investigational Site
Hamburg, 22291
Otsuka Investigational Site
Leipzig, 04289
Otsuka Investigational Site
Pirna, 01796
Italy4 sites
Otsuka Investigational Site
Ancona, 60126
Otsuka Investigational Site
Bologna, 40138
Otsuka Investigational Site
Cremona, 26100
Otsuka Investigational Site
San Fermo, Como, 22100
Netherlands2 sites
Otsuka Investigational Site
Amsterdam, 1105AZ
Otsuka Investigational Site
Groningen, 9713GZ
United Kingdom1 site
Otsuka Investigational Site
Chertsey, Surrey, KT160PZ
About this study
Official title: A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects With Paroxysmal and Persistent Atrial Fibrillation
The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).
The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.
Read the detailed description
This trial will test the pharmacokinetic and pharmacodynamic characteristics of ascending doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects.
The trial will consist of two parts. Each part will evaluate two populations of subjects presenting for cardioversion in a hospital setting.
Cohorts of paroxysmal and persistent subjects may have their dose increased independently.
- Being tested
- OPC-108459, Placebo
- Keywords
- Atrial fibrillation, Paroxysmal Atrial fibrillation, Persistent Atrial fibrillation, A-fib
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-108459Drug
Also called 269-11-215
Part 1: single dose OPC-108459, 10-minute constant rate IV infusion to achieve specified Cmax target
Part 2: single dose OPC-108459, 10-minute constant rate IV infusion to achieve Cmax target concentration from Part 1; if failure to convert to sinus rhythm, second dose OPC-108459 administered, 10-minute constant rate IV infusion to achieve target concentration from Part 1
PlaceboDrug
Placebo dose, 10-minute constant rate IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Persistent or Paroxysmal AF Part 1: OPC-108459 | Experimental | To safely meet each of the following Cmax targets: 1.0-10.0 µg/mL. There will be 9 cohorts in all: 1.0, 1.6, 2.4, 3.6, 5.4, 7.0, 8.0, 9.0, and 10.0. Receives: Drug: OPC-108459 |
| Persistent or Paroxysmal AF Part 1: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Persistent or Paroxysmal AF Part 2: OPC-108459 | Experimental | Single dose to safely meet target concentration from Part 1, if subject fails to convert to sinus rhythm within 10 minutes, second dose will be administered to achieve 25% increase when compared to first infusion Receives: Drug: OPC-108459 |
| Placebo Part 2 | Placebo comparator | Not described Receives: Drug: OPC-108459; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Maximum (Peak) Plasma Concentration (Cmax)
OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion.
Measured: 24 hours
Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ)
OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post infusion.
Measured: 24 hours
Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion
12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.
Measured: 24 hours
Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion
12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.
Measured: 24 hours
Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion
Maximum change from baseline in diastolic and systolic blood pressure(BP) collected during vital sign measurements in the 24-hour postdose interval. Participants must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic <100 mmHg. BP was measured after at least 3 minutes in the supine position. BP was measured at predose (within 45 minutes of dosing); 3 and 7 minutes and approximately 1, 4, 8, 12, and 24 hours.
Measured: 24 hours
Part 2/1 Infusion: Cmax
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2/2 Infusions: Cmax
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2/1 Infusion: AUCt
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2/2 Infusions: AUCt
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2: QTcF
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2: Ventricular Rate
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2: Diastolic and Systolic Blood Pressure
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2: Percentage of Subjects With Normal Sinus Rhythm (NSR)
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Secondary outcomes (4)
Part 1: Percentage of Participants With NSR
Percent of participants with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion.
Measured: 30 minutes
Part 2: Time to NSR
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2: Duration of NSR
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 24 hours
Part 2: Duration of NSR
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Measured: 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Enrollment Difficulty
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483183
- Sponsor's protocol ID
- 269-11-215
- Acronym
- CADENCE 215
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2011
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects With Paroxysmal and Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01483183
- Acronym / sponsor ID
- CADENCE 215 / 269-11-215
- Keywords
- Atrial fibrillation, Paroxysmal Atrial fibrillation, Persistent Atrial fibrillation, A-fib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment Difficulty
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).
The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.
Detailed description
This trial will test the pharmacokinetic and pharmacodynamic characteristics of ascending doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects.
The trial will consist of two parts. Each part will evaluate two populations of subjects presenting for cardioversion in a hospital setting.
Cohorts of paroxysmal and persistent subjects may have their dose increased independently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Persistent or Paroxysmal AF Part 1: OPC-108459 | Experimental | Drug: OPC-108459To safely meet each of the following Cmax targets: 1.0-10.0 µg/mL. There will be 9 cohorts in all: 1.0, 1.6, 2.4, 3.6, 5.4, 7.0, 8.0, 9.0, and 10.0. |
| Persistent or Paroxysmal AF Part 1: Placebo | Placebo comparator | Drug: Placebo |
| Persistent or Paroxysmal AF Part 2: OPC-108459 | Experimental | Drug: OPC-108459Single dose to safely meet target concentration from Part 1, if subject fails to convert to sinus rhythm within 10 minutes, second dose will be administered to achieve 25% increase when compared to first infusion |
| Placebo Part 2 | Placebo comparator | Drug: OPC-108459, Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with paroxysmal atrial fibrillation (AF) (recent or new onset) or subjects with persistent AF at the time of randomization
- Subjects who are hemodynamically stable
- Subjects with a low risk of thromboembolic potential
- Subjects who are willing to comply with the reproductive precautions
Key exclusion criteria (19 listed)
- History of long QT syndrome, Torsade de Pointes or an uncorrected QT interval of > 450 ms
- History of myocardial infarction within 6 months of screening
- Acute coronary syndrome, angina or active myocardial ischemia diagnosed by ECG, or other imaging within 6 months of screening
- History of ventricular tachycardia, fibrillation, or resuscitated cardiac arrest
- History of clinically significant congenital heart 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 |
|---|---|---|
| OPC-108459Also: 269-11-215Part 1: single dose OPC-108459, 10-minute constant rate IV infusion to achieve specified Cmax target Part 2: single dose OPC-108459, 10-minute constant rate IV infusion to achieve Cmax target concentration from Part 1; if failure to convert to sinus rhythm, second dose OPC-108459 administered, 10-minute constant rate IV infusion to achieve target concentration from Part 1 | Drug | Persistent or Paroxysmal AF Part 1: OPC-108459, Persistent or Paroxysmal AF Part 2: OPC-108459, Placebo Part 2 |
| PlaceboPlacebo dose, 10-minute constant rate IV infusion | Drug | Persistent or Paroxysmal AF Part 1: Placebo, Placebo Part 2 |
Primary outcome
Part 1: Maximum (Peak) Plasma Concentration (Cmax)
Time frame: 24 hours
OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion.
Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ)
Time frame: 24 hours
OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post infusion.
Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion
Time frame: 24 hours
12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.
Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion
Time frame: 24 hours
12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.
Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion
Time frame: 24 hours
Maximum change from baseline in diastolic and systolic blood pressure(BP) collected during vital sign measurements in the 24-hour postdose interval. Participants must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic <100 mmHg. BP was measured after at least 3 minutes in the supine position. BP was measured at predose (within 45 minutes of dosing); 3 and 7 minutes and approximately 1, 4, 8, 12, and 24 hours.
Part 2/1 Infusion: Cmax
Time frame: 24 hours
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Part 2/2 Infusions: Cmax
Time frame: 24 hours
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Part 2/1 Infusion: AUCt
Time frame: 24 hours
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Part 2/2 Infusions: AUCt
Time frame: 24 hours
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Part 2: QTcF
Time frame: 24 hours
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Part 2: Ventricular Rate
Time frame: 24 hours
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Part 2: Diastolic and Systolic Blood Pressure
Time frame: 24 hours
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Part 2: Percentage of Subjects With Normal Sinus Rhythm (NSR)
Time frame: 24 hours
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
4 secondary outcomes
Part 1: Percentage of Participants With NSR
Time frame: 30 minutes
Part 2: Time to NSR
Time frame: 24 hours
Part 2: Duration of NSR
Time frame: 24 hours
Part 2: Duration of NSR
Time frame: 168 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPC-108459 in people with Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 25 sites in 6 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 4 inclusion and 19 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Spain, Germany, Italy, Netherlands and 1 more country. 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 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?
Yes. Results are posted in the registry (first posted 10 Apr 2017). 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?
Part 1: Maximum (Peak) Plasma Concentration (Cmax) (time frame: 24 hours). The study lists 13 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 10 Apr 2017.