Chronic Obstructive Pulmonary DiseasePhase 2NCT01349803

PT003 MDI Cardiovascular Safety Study

A Phase 2 study testing PT005 MDI, PT001 MDI and PT003 MDI in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 20 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: PT005 MDI, PT001 MDI and PT003 MDI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 237 participants
Where: 20 sitesin 3 countries
Study dates: May 2011to Nov 2011
Phase: Phase 2
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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
Current/former smokers with at least a 10 pack-year history of cigarette smoking
A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70

Show all 9Show fewer

A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
Able to change COPD treatment as required by protocol
Acceptable baseline (Visit 2) Holter monitor recording

Who cannot join

Women who are pregnant or lactating
Primary diagnosis of asthma
Alpha-1 antitrypsin deficiency as the cause of COPD
Active pulmonary diseases
Prior lung volume reduction surgery
Abnormal chest X-ray (or CT scan) not due to the presence of COPD

Show all 13Show fewer

Hospitalized due to poorly controlled COPD within 3 months of Screening
Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
Cancer that has not been in complete remission for at least 5 years
Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
Clinically significant abnormal findings during the baseline Holter recording
Patients with a pacemaker or ICD/CRT/CRT_D devices
Other inclusion/exclusion criteria as defined by the protocol

Trial locations and contacts

20 sites in 3 countries.

Country

City, postcode or hospital

20 sites in 3 countries

United States10 sites

Pearl Investigative Site
Fullerton, California
Pearl Investigative Site
Glendale, Arizona
Pearl Investigative Site
Lafayette, Louisiana
Pearl Investigative Site
Livonia, Michigan
Pearl Investigative Site
Los Angeles, California
Pearl Investigative Site
Medford, Oregon
Pearl Investigative Site
North Dartmouth, Massachusetts
Pearl Investigative Site
Pensacola, Florida
Pearl Investigative Site
San Antonio, Texas
Pearl Investigative Site
San Diego, California

Other trials in United States

Australia6 sites

Pearl Investigative Site
Caboolture, Queensland
Pearl Investigative Site
Dawpark, South Australia
Pearl Investigative Site
Glebe, New South Wales
Pearl Investigative Site
Heidelberg, Victoria
Pearl Investigative Site
Nedlands, Western Australia
Pearl Investigative Site
Toorak Gardens, South Australia

Other trials in Australia

New Zealand4 sites

Pearl Investigative Site
Caversham, Dunedin
Pearl Investigative Site
Newtown, Wellington Region
Pearl Investigative Site
Private Bag, Hamilton
Pearl Investigative Site
Tauranga, North Island

Other trials in New Zealand

About this study

Official title: A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: PT005 MDI, PT001 MDI, PT003 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PT005 MDIDrug
PT005 MDI administered as two puffs BID for 14 days
PT001 MDIDrug
PT001 MDI administered as two puffs BID for 14 days
PT003 MDIDrug
PT003 MDI administered as two puffs BID for 14 days
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Drug
Also called Foradil® Aerolizer®
Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days

Study groups in NCT01349803
Study group	Role	What they receive
PT005 MDI	Experimental	PT005 MDI Receives: Drug: PT005 MDI
PT001 MDI	Experimental	PT001 MDI Receives: Drug: PT001 MDI
PT003 MDI	Experimental	PT003 MDI Receives: Drug: PT003 MDI
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Active comparator	Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Receives: Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

What is being measured

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

Change From Baseline in 24-Hour Mean Heart Rate Post-dose
The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Measured: 14 days

Secondary outcomes (15)

Change From Baseline in Mean FEV1 Trough
Trough FEV1 averaged over Day 7 and Day 14
Measured: Day 7 to Day 14
Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: 24 hours
Change From Baseline in Daytime Mean Heart Rate
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in Night Time Mean Heart Rate
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in 24-Hour Maximum Heart Rate
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in 24-Hour Minimum Heart Rate
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, and Day 14
Mean Change From Baseline in QTcF Interval
The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).
Measured: Baseline, Day 1, Day 7, and Day 14

Timeline

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

May 2011Nov 2011

First posted9 May 2011 (estimated)
Study startMay 2011
Primary completionNov 2011
Study completionNov 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 237 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01349803
Sponsor's protocol ID: PT003003
Status last verified: Nov 2016
First submitted: 5 May 2011
Last updated: 31 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ferguson GT, Reisner C, Pearle J, DePetrillo P, Maes A, Martin UJ. Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology. Pulm Pharmacol Ther. 2018 Apr;49:67-74. doi: 10.1016/j.pupt.2018.01.007. Epub 2018 Feb 4.
PubMed 29567116

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01349803
Acronym / sponsor ID: PT003003
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 237 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 9 May 2011 (estimated)
Results: Posted 31 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
PT005 MDI	Experimental	Drug: PT005 MDIPT005 MDI
PT001 MDI	Experimental	Drug: PT001 MDIPT001 MDI
PT003 MDI	Experimental	Drug: PT003 MDIPT003 MDI
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Active comparator	Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
Current/former smokers with at least a 10 pack-year history of cigarette smoking

Key exclusion criteria (13 listed)

Women who are pregnant or lactating
Primary diagnosis of asthma
Alpha-1 antitrypsin deficiency as the cause of COPD
Active pulmonary diseases
Prior lung volume reduction surgery

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
PT005 MDIPT005 MDI administered as two puffs BID for 14 days	Drug	PT005 MDI
PT001 MDIPT001 MDI administered as two puffs BID for 14 days	Drug	PT001 MDI
PT003 MDIPT003 MDI administered as two puffs BID for 14 days	Drug	PT003 MDI
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Also: Foradil® Aerolizer®Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days	Drug	Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Primary outcome

Change From Baseline in 24-Hour Mean Heart Rate Post-dose
Time frame: 14 days
The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

15 secondary outcomes

Change From Baseline in Mean FEV1 Trough
Time frame: Day 7 to Day 14
Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment
Time frame: 24 hours
Change From Baseline in Daytime Mean Heart Rate
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in Night Time Mean Heart Rate
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in 24-Hour Maximum Heart Rate
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in 24-Hour Minimum Heart Rate
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring
Time frame: Baseline, Day 1, and Day 14
Mean Change From Baseline in QTcF Interval
Time frame: Baseline, Day 1, Day 7, and Day 14

Results and safety

Results posted to the registry on 31 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FF MDI (PT005)	60	59
GP MDI (PT001)	58	57
GFF MDI (PT003)	60	57
Foradil® Aerolizer®	59	57

Primary outcome: Change From Baseline in 24-Hour Mean Heart Rate Post-dose

Time frame: 14 days. Least squares mean (95% Confidence Interval). Unit: bpm

Measure	FF MDI (PT005) n = 59	GP MDI (PT001) n = 57	GFF MDI (PT003) n = 55	Foradil® Aerolizer® n = 55
Value	-0.19 (-1.38 to 1.00)	-1.84 (-3.05 to -0.63)	0.40 (-0.84 to 1.63)	-0.09 (-1.32 to 1.15)

Population analysed: Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) and Serious Adverse Events (SAEs) were collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FF MDI (PT005)	1 of 60 (1.7%)	6 of 60 (10%)	Not reported
GP MDI (PT001)	0 of 58 (0%)	4 of 58 (6.9%)	Not reported
GFF MDI (PT003)	1 of 60 (1.7%)	2 of 60 (3.3%)	Not reported
Foradil® Aerolizer®	1 of 59 (1.7%)	5 of 59 (8.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29567116Ferguson GT, Reisner C, Pearle J, DePetrillo P, Maes A, Martin UJ. Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology. Pulm Pharmacol Ther. 2018 Apr;49:67-74. doi: 10.1016/j.pupt.2018.01.007. Epub 2018 Feb 4.

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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.

Colin Reisner, M.D. study director

Pearl Therapeutics

20 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PT005 MDI, PT001 MDI and PT003 MDI in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 20 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 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Australia, New Zealand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 31 Jan 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?

Change From Baseline in 24-Hour Mean Heart Rate Post-dose (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01349803, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.