Prostate CancerNCT01234350

A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

An observational study of Prostate Cancer, run by Ferring Pharmaceuticals at 160 sites in 15 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

Who is it for?: Any age, men only
Conditions the study is for: Prostate Cancer
How many people: 1,493 participants
Where: 160 sitesin 15 countries
Study dates: Jan 2011to 27 Mar 2018
Phase: Observational
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 Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Study population: Subjects with prostate cancer from primary care

Who may be able to join

Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT)
Decision made to prescribe ADT prior to enrolment
Willing and able to provide written informed consent

Who cannot join

Participation in an interventional clinical study in which any treatment or follow-up is mandated
Treatment with a GnRH receptor antagonist other than FIRMAGON
Had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be terminated at least 6 months prior to baseline.

Trial locations and contacts

160 sites in 15 countries.

Country

City, postcode or hospital

160 sites in 15 countries

France27 sites

CHRU Angers
Angers
Centre Hospitalier d'Athis Mons site Caron
Athis-Mons
Hopital Tenon
Aubervilliers
Clinique Rhone Durance
Avignon
CHU Saint-Jacques
Besançon
Centre Hospitalier Laennec
Clermont-Ferrand
Chu Gabriel Montpied
Clermont-Ferrand
Ramsay Sante
Évry
Groupement hospitalier Edouard Herriot
Lyon
Cabinet Médical 65 prado
Marseille
CHU Nord
Marseille
Hopital de la Conception
Marseille
Polyclinique Saint-Jean
Melun
Clinique du Pont de Chaume
Montauban
Clinique Beausoleil
Montpellier
Centre d'Urologie de Nancy
Nancy
Hôpital Max Fourestier
Nanterre
Groupe hospitalo-universitaire Caremeau
Nîmes
Centre Hospitalier Georges Renon
Niort
Hopital Tenon
Paris
Clinique du Ter
Ploemeur
Clinic De L'Europe
Pontoise
Hopital Pontchaillou
Rennes
Clinique Saint Michel
Toulon
Clinique St Jean Languedoc
Toulouse
Hopital Bretonneau
Tours
CHU Brabois
Vandœuvre-lès-Nancy

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Germany22 sites

Gemeinschaftspraxis Dres Effert und Benedic
Aachen
Praxis Dr. Schlichter
Bad Bergzaben
Praxis Dr. Markus Hentschel
Bautzen
Praxis Dr. Richter
Bonn
Urologie im Schlosscarree
Braunschweig
Praxis Dr. Ahmad Haider
Bremerhaven
Praxis Dr. Krieger
Chemnitz
Urologie Chemnitz
Chemnitz
Praxis Dr. Thomas Harms
Cologne
Gemeinschaftspraxis fur Urologie
Dachau
Klinikpraxis fur Urologie
Dinslaken
Praxis Dr. Schönfelder
Hamburg
Gemeinschaftspraxis Urologie
Kiel
Urologische Gemeinschaftspraxis
Kiel
Gemeinshaftspraxis Rudolph & Wörner
Kirchheim
Vituro
Leipzig
Praxis Alexander von Keitz
Marburg
Praxis Dr. Peczat
Nienburg
Studienzentrum München-Planegg
Planegg
Urologische Gemeinschaftspraxis
Reutlingen
Praxis Dr. Jan Franz
Tostedt
Praxis fur Urologie
Wuppertal

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Greece21 sites

"Agios Savas" Anticancer-Oncology Hospital of Athens
Athens
"G. Gennimtas" General Hospital of Athens
Athens
"Laiko" General Hospital of Athens
Athens
Amalia Fleming General Hospital of Athens
Athens
Errikos Dynan Hospital of Athens
Athens
Eurokliniki Hospital of Athens
Athens
Evaggelismos General Hospital
Athens
General Hospital of Athens "Ag. Olga" - Konstantopouleion
Athens
Ippokrateio Hospital of Athens
Athens
Korgialenio-Benakio
Athens
Pe. Pa.G.N:I Hospital
Heraklion
General hospital of Kalamata
Kalamata
IASO General Hospital
Kalamata
University Hospital of Larissa
Larissa
Aghios Andreas General Hospital of Patras
Pátrai, Greece
University General Hospital of Patras
Pátrai
General Hospital of Piraeus "Tzanneio"
Piraeus
"G. Gennimtas" General Hospital of Thessaloniki
Thessaloniki
2nd IKA-ETAM "Panagia" General Hospital of Thessaloniki
Thessaloniki
Papageorgiou General Hospital of Thessaloniki
Thessaloniki
General Hospital of Volos "Achillopouleio"
Volos

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Slovakia18 sites

VEBMED, s.r.o.
Bošany
CUIMED, s.r.o.
Bratislava
Nemocnica Svateho Michala, a.s.
Bratislava
Univerzitna nemocnica Bratislava
Bratislava
URO clinic, s.r.o.
Bratislava
Poliklinika Galanta
Galanta
MEDICONA s.r.o.
Košice
UROCENTRUM LEVICE, s.r.o.
Levice
Poliklinika Malacky
Malacky
Univerzitna nemocnica Martin
Martin
UROEXAM, spol. s r.o.
Nitra
CENTRUM UROLOGIE Povazska Bystrica s.r.o
Považská Bystrica
MILAB, s.r.o.
Prešov
UROCENTRUM SALA, s.r.o.
Šaľa
Nemocnica s poliklinikou Skalica, a.s.
Skalica
M & M & M, s.r.o.
Topoľčany
PRIVATNA UROLOGICKA AMBULANCIA s.r.o.
Trenčín
UROREX, s.r.o.
Vráble

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Belgium17 sites

Onze-Lieve-Vrouwziekenhuis
Aalst
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
Antwerp
AZ Sint-Jan AV
Bruges
Hôpitaux IRIS Sud
Brussels
Université Catholique de Louvain
Brussels
Hôpital Erasme
Bruxelle
AZ Sint-Blasius
Dendermonde
AZ Jan Palfijn
Ghent
AZ Maria Middelares
Ghent
AZ Sint-Lucas
Ghent
UZ Gent
Ghent
Regionaal Ziekenhuis Jan Yperman VZW
Ieper
AZ Groeninge - Campus Sint-Maarten
Kortrijk
CHU de Liège
Liège
Centre Hospitalier Universitaire Ambroise Paré
Mons
AZ Damiaan
Ostend
AZ-Sint-Elizabeth VZW
Zottegem

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Italy13 sites

Medical Consulting Center S.r.l.
Avellino
Azienda Sanitaria Regionale del Molise (ASREM)
Campobasso
Azienda Ospedaliera Mater Domini di Catanzaro
Catanzaro
Azienda Ospedaliera Carlo Poma
Mantua
Ospedale Luigi Sacco
Milan
Azienda Ospedaliera Monaldi
Naples
Azienda Sanitaria Locale Salerno
Nocera Inferiore
Ospedale Santa Maria delle Croci
Ravenna
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria
Istituto Nazionale Tumori "Regina Elena"
Roma
Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona
Salerno
ASL 4 di Teramo
Teramo
Ospedale "San Pio da Pietrelcina"
Vasto

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Denmark6 sites

Aalborg Sygehus
Aalborg
Rigshospitalet
Copenhagen
Fredericia Hospital, Sygehus Lillebaelt
Fredericia
Herlev Hospital
Herlev
Holstebro Sygehus
Holstebro
Regionhospitalet Viborg
Viborg

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Finland6 sites

Docrates clinic
Helsinki
Pohjois-Karjalan keskussairaala
Joensuu
Seinäjoen keskussairaala
Seinäjoki
Tampereen yliopistollinen sairaala
Tampere
Turun yliopistollinen keskussairaala
Turku
Peijaksen sairaala
Vantaa

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Hungary6 sites

Azarka Zsuzsanna és Társa Bt
Budapest
UROFOR Bt
Debrecen
Kiskunhalasi Semmelweis Kórház Kht.
Kiskunhalas
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
Miskolc
Uro-Clin Kft
Pécs
FEjér Megyei Szent György Kórhaz
Székesfehérvár

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United Kingdom6 sites

Homerton University Hospital
London
Kings College Hospital
London
Royal Marsden Hospital
London
Whipps Cross Hospital
London
East Surrey Hospital
Redhill
Sunderland Royal Hospital
Sunderland

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Netherlands5 sites

AMC
Amsterdam
Catharina ziekenhuis
Eindhoven
Groene Hart Ziekenhuis
Gouda
Diaconessenhuis Leiden
Leiden
MC Haaglanden
The Hague

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Norway5 sites

Vestre Viken HF, Sykehuset Asker og Baerum
Asker
Haukeland Universitetssykehus
Bergen
Helse Nordmore og Romsdal HF, Kristiansund Sykehus
Kristiansund
Olso Universitetssykehus HF, Radiumhospitalet
Oslo
Oslo Universitetssykehus, Aker
Oslo

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Ireland3 sites

Beacon Hospital
Dublin
Beaumont Hospital
Dublin
University College Hospital
Galway

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Portugal3 sites

Clinica de Santo Antonio
Lisbon
Hospital Militar
Lisbon
Hospital Santa Maria
Lisbon

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Switzerland2 sites

Universitätsspital Basel
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Urozentrum Zürich
Zurich

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About this study

Official title: A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist

This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

Conditions: Prostate Cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

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

Study groups in NCT01234350
Study group	Role	What they receive
FIRMAGON		Not described
GnRH Agonist		Not described

What is being measured

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

Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events
The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Incidence Rate of AESI: Decreased Bone Density
IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)
IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE.
Glucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Change in Hepatic Enzymes
Change from baseline in hepatic enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase [ALP]) are presented.
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Change in Hepatic Enzymes
Change from baseline in hepatic enzyme level (bilirubin) is presented.
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Change in Serum Glucose
Change from baseline in serum glucose are presented.
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Secondary outcomes (4)

Number and Classification of New Adverse Drug Reactions (ADRs)
An ADR was defined as an AE assessed by investigator as possibly/probably related to the investigational product. Any new potentially unrecognized ADRs were presented.
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Long Term Evaluation of Clinical Evolution of Prostate Cancer
Change in prostate specific antigen (PSA) is presented.
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Changes in Testosterone Levels
Change from baseline in testosterone levels are presented.
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
All-cause of Mortality
A summary of IRs of all-cause mortality is presented.
Measured: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Timeline

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

Jan 201127 Mar 2018

First posted4 Nov 2010 (estimated)
Study startJan 2011
Primary completion27 Mar 2018
Study completion27 Mar 2018

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 Prostate CancerStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,493 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01234350
Sponsor's protocol ID: FE200486 CS39
Status last verified: Jun 2019
First submitted: 3 Nov 2010
Last updated: 25 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist
ClinicalTrials.gov ID: NCT01234350
Acronym / sponsor ID: FE200486 CS39
Conditions: Prostate Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 1,493 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: 27 Mar 2018 (actual)
Study completion: 27 Mar 2018 (actual)
First posted: 4 Nov 2010 (estimated)
Results: Posted 20 May 2019

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
FIRMAGON	–	–
GnRH Agonist	–	–

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Subjects with prostate cancer from primary care

Key inclusion criteria (3 listed)

Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT)
Decision made to prescribe ADT prior to enrolment
Willing and able to provide written informed consent

Key exclusion criteria (3 listed)

Participation in an interventional clinical study in which any treatment or follow-up is mandated
Treatment with a GnRH receptor antagonist other than FIRMAGON
Had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be terminated at least 6 months prior to baseline.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).
Incidence Rate of AESI: Decreased Bone Density
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.
Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE. Glucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L
Change in Hepatic Enzymes
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Change from baseline in hepatic enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase [ALP]) are presented.
Change in Hepatic Enzymes
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Change from baseline in hepatic enzyme level (bilirubin) is presented.
Change in Serum Glucose
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Change from baseline in serum glucose are presented.

4 secondary outcomes

Number and Classification of New Adverse Drug Reactions (ADRs)
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Long Term Evaluation of Clinical Evolution of Prostate Cancer
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Changes in Testosterone Levels
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
All-cause of Mortality
Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Results and safety

Results posted to the registry on 20 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FIRMAGON	1,000	313
GnRH Agonist	493	226

Primary outcome: Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study). Number. Unit: Events per 100 PYE

Measure	FIRMAGON n = 1000	GnRH Agonist n = 493
Value	3.8	4.5

FIRMAGON vs GnRH Agonist: IRR: 0.829 (95% CI 0.536 to 1.283), p = 0.4007, Wald test

Population analysed: The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).

Primary outcome: Incidence Rate of AESI: Decreased Bone Density

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study). Number. Unit: Events per 100 PYE

Measure	FIRMAGON n = 1000	GnRH Agonist n = 493
Osteoporosis or Osteopenia	1.1	1.4
Bone fracture	0.3	0.1

FIRMAGON vs GnRH Agonist: IRR: 0.874 (95% CI 0.470 to 1.626), p = 0.6710, Wald test
FIRMAGON vs GnRH Agonist: IRR: 1.857 (95% CI 0.367 to 9.403), p = 0.4544, Wald test

Primary outcome: Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study). Number. Unit: Events per 100 PYE

Measure	FIRMAGON n = 1000	GnRH Agonist n = 493
Glucose intolerance	15.3	13.2
T2DM	1.8	0.7

FIRMAGON vs GnRH Agonist: IRR: 1.193 (95% CI 0.882 to 1.613), p = 0.2529, Wald test
FIRMAGON vs GnRH Agonist: IRR: 2.623 (95% CI 1.158 to 5.944), p = 0.0208, Wald test

Primary outcome: Change in Hepatic Enzymes

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study). Median (Full Range). Unit: IU/L

Measure	FIRMAGON n = 1000	GnRH Agonist n = 493
ALT (Visit 2, Month 3)	0.1 (-70 to 63)	0.1 (-19 to 82)
ALT (Visit 3, Month 6)	0.1 (-65 to 174)	0.1 (-41 to 125)
ALT (Visit 4, Month 9)	0.0 (-66 to 55)	0.0 (-22 to 54)
ALT (Visit 5, Month 12)	0.0 (-63 to 57)	0.0 (-38 to 49)
ALT (Visit 6, Month 15)	-0.1 (-69 to 30)	0.0 (-44 to 37)
ALT (Visit 7, Month 18)	-0.1 (-68 to 41)	0.1 (-26 to 77)
ALT (Visit 8, Month 21)	-0.1 (-70 to 204)	0.1 (-25 to 49)
ALT (Visit 9, Month 24)	-0.1 (-65 to 332)	0.0 (-24 to 20)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FIRMAGON	236 of 1,000 (23.6%)	294 of 1,000 (29.4%)	141 of 1,000
GnRH Agonist	144 of 493 (29.2%)	110 of 493 (22.3%)	72 of 493

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationObservational study
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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.

Global Clinical Compliance study director

Ferring Pharmaceuticals

160 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Ferring Pharmaceuticals at 160 sites in 15 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 3 inclusion and 3 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in France, Germany, Greece, Slovakia, Belgium and 10 more countries. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2019). 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?

Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events (time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)). 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?

On the ClinicalTrials.gov record for NCT01234350.

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 25 Jun 2019.