Heart FailurePhase 2PANACHENCT03098979

A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction

A Phase 2 study testing Neladenoson bialanate (BAY1067197) in people with Heart Failure, run by Bayer at 76 sites in 12 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

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Heart Failure
What is being tested?: Neladenoson bialanate (BAY1067197)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 305 participants
Where: 76 sitesin 12 countries
Study dates: 10 May 2017to 20 Jun 2018
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women aged 45 years and older
Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP

Who cannot join

Acute decompensated heart failure within the past 4 weeks
Inability to exercise
Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF < 40%)

Trial locations and contacts

76 sites in 12 countries.

Country

City, postcode or hospital

76 sites in 12 countries

Japan14 sites

Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, 660-8550
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, 251-0041
Fukui Prefectural Hospital
Fukui, 910-8526
Minamino Cardiovascular Hospital
Hachiōji, Tokyo, 192-0918
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-8522
R.I.A.C Naha City Hospital
Naha, Okinawa, 902-8511
Okayama Rosai Hospital
Okayama, 702-8055
Osaka General Medical Center
Osaka, 558-8558
Chuno kosei Hospital
Sekimachi, Gifu, 501-3802
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1096
Osaka Medical College Hospital
Takatsuki, Osaka, 569-8686
Tokushima Prefectural Central Hospital
Tokushima, 770-8539

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Spain8 sites

Hospital Sanitas La Zarzuela
Aravaca, Madrid, 28023
Hospital del Mar
Barcelona, 08003
Hospital Universitario "Virgen de la Arrixaca"
El Palmar, Murcia, 30120
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Clínico Universitario San Carlos
Madrid, 28040
Hospital Virgen de la Victoria
Málaga, 29010
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital Universitari i Politècnic La Fe
Valencia, 46026

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Israel7 sites

Barzilai Medical Center
Ashkelon, 7830604
Hillel Yaffe Medical Center
Hadera, 3810101
Rambam Health Corporation
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah University Hospital Mount Scopus
Jerusalem
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
Assaf Harofeh Medical Center
Zrifin, 6093000

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Italy7 sites

AUSL Toscana Sud-Est
Arezzo, Tuscany, 52040
ASST Papa Giovanni XXIII
Bergamo, Lombardy, 24127
ASST Spedali Civili di Brescia
Brescia, Lombardy, 25123
A.O.U. Sant'Andrea
Rome, Lazio, 00189
A.O.U. di Sassari
Sassari, Sardinia, 07100
A.O. Ordine Mauriziano
Turin, Piedmont, 10128
AAS 3 Friuli Alto Medio Collin
Udine, Friuli Venezia Giulia, 33038

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Poland7 sites

Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
Szpital Zachodni w Grodzisku Mazowieckim
Grodzisk Mazowiecki, 05-825
Szpital Specjalistyczny im. J. Dietla
Krakow, 31-121
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego
Lodz, 91-347
109 Szpital Wojskowy z przychodnia SPZOZ
Szczecin, 70-965
Szpital Wolski im. dr Anny Gostynskiej SPZOZ
Warsaw, 02-211
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
Wroclaw, 50-981

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Austria6 sites

Krankenhaus St. Josef Braunau
Braunau am Inn, Upper Austria, 5280
Medizinische Universität Graz
Graz, Styria, 8036
Krankenhaus der Elisabethinen Linz GmbH
Linz, Upper Austria, 4020
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, 3100
Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090
Krankenhaus Hietzing
Vienna, 1130

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Bulgaria6 sites

Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
Pernik, 2300
Specialized Hospital for Actrive Treatm of Card - Pleven
Pleven, 5800
Medical Center Cardiohelp
Sofia, 1142
NMTH Tzar Boris III
Sofia, 1233
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, 1527
MCOMH Preventsia-2000
Stara Zagora, 6000

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Greece6 sites

G. Gennimatas General State Hospital of Athens
Athens, 11527
General Hospital of Chalkida
Chalcis, 34100
KAT General Hospital of Athens
Kifisia / Athens, Attica, 14561
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
Nea Ionia / Athens, 142 33
Hippokration General Hospital of Thessaloniki
Thessaloniki, 54642
Asklipieion General Hospital of Voulas
Voula, 16673

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United States4 sites

Northwestern University
Chicago, Illinois, 60611
BryanLGH Medical Center East
Lincoln, Nebraska, 68506
St. Louis Heart & Vascular, PC
St Louis, Missouri, 63136
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157-1045

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Germany4 sites

Charité Campus Virchow-Klinikum (CVK)
Berlin, 13353
Klinische Forschung Dresden GmbH
Dresden, Saxony, 01069
HELIOS Klinikum Erfurt GmbH
Erfurt, Thuringia, 99089
St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
Mainz, Rhineland-Palatinate, 55131

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Portugal4 sites

CHUC - Hospitais da Universidade de Coimbra
Coimbra, 3000-075
CHLO - Hospital São Francisco Xavier
Lisbon, 1449-005
Hospital da Luz
Lisbon, 1500-650
CHUP, EPE - Hospital de Santo Antonio
Porto, 4099-001

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Belgium3 sites

Jessa Ziekenhuis
Hasselt, 3500
CHR de la Citadelle
Liège, 4000
AZ Delta
Roeselare, 8800

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About this study

Official title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetics and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure and Preserved Ejection Fraction

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.

Conditions: Heart Failure
Being tested: Neladenoson bialanate (BAY1067197), Placebo
Keywords: Chronic Heart Failure, Heart Failure with Preserved Ejection Fraction
Medical subject headings: Heart Failure

What participants receive

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

Neladenoson bialanate (BAY1067197)Drug
5 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)Drug
10 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)Drug
20 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)Drug
30 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)Drug
40 mg orally once daily for 20 weeks
PlaceboDrug
Orally once daily for 20 weeks

Study groups in NCT03098979
Study group	Role	What they receive
Neladenoson bialanate (BAY1067197) (5 mg)	Experimental	Chronic heart failure with preserved ejection fraction Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (10 mg)	Experimental	Chronic heart failure with preserved ejection fraction Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (20 mg)	Experimental	Chronic heart failure with preserved ejection fraction Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (30 mg)	Experimental	Chronic heart failure with preserved ejection fraction Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (40 mg)	Experimental	Chronic heart failure with preserved ejection fraction Receives: Drug: Neladenoson bialanate (BAY1067197)
Placebo	Placebo comparator	Chronic heart failure with preserved ejection fraction Receives: Drug: Placebo

What is being measured

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

Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
Measured: Baseline, and up to 20 weeks of treatment

Secondary outcomes (4)

Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity
AVIVO™ Mobile Patient Management System, a wearable wireless device worn by the subject, was used to monitor subjects' cardiovascular status. The patient's everyday physical activity e.g. duration, intensity, was also tracked by the AVIVO device. For Activity Intensity, the Unit of Measure is "percentage of maximum activity", and length of intervals is "daily".
Measured: Baseline, and up to 20 weeks of treatment
Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks
NT-proBNP = N-terminal pro-hormone b-type natriuretic peptide
Measured: Baseline, and up to 20 weeks of treatment
Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks
High sensitivity troponin T (hs-TNT) was measured
Measured: Baseline, and up to 20 weeks of treatment
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
The KCCQ is the leading health-related quality-of-life measure for patients with chronic heart failure (CHF). It is a 23-item questionnaire that independently measures the impact of patient's heart failure (HF), or its treatment, on 7 distinct domains: 1) Symptom Frequency 2) Symptom Burden 3) Physical Limitation 4) Quality of Life 5) Social Limitations 6) Self-efficacy 7) Symptoms Stability.
Overall summary score= mean score of (symptom frequency + symptom burden+ physical limitation + quality of life + social limitation); scores on a scale of 0 to 100, higher scores means better outcome; Physical Limitation: scores on a scale of 0 to 100, higher scores means better outcome; Total symptom score=mean score of (symptom frequency + symptom burden): scores on a scale of 0 to 100, higher scores means better outcome.
Positive change means improvement and negative change means deterioration.
Measured: Baseline, and up to 20 weeks of treatment

Timeline

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

10 May 201720 Jun 2018

First posted4 Apr 2017
Study start10 May 2017
Primary completion23 May 2018
Study completion20 Jun 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by BayerThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 305 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03098979
Sponsor's protocol ID: 17582
Other IDs: 2016-004062-26, 2016
Acronym: PANACHE
Status last verified: Jul 2019
First submitted: 15 Mar 2017
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Shah SJ, Voors AA, McMurray JJV, Kitzman DW, Viethen T, Bomfim Wirtz A, Huang E, Pap AF, Solomon SD. Effect of Neladenoson Bialanate on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2101-2112. doi: 10.1001/jama.2019.6717.
PubMed 31162568

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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetics and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure and Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT03098979
Acronym / sponsor ID: PANACHE / 17582
Conditions: Heart Failure
Keywords: Chronic Heart Failure, Heart Failure with Preserved Ejection Fraction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 305 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 10 May 2017 (actual)
Primary completion: 23 May 2018 (actual)
Study completion: 20 Jun 2018 (actual)
First posted: 4 Apr 2017 (actual)
Results: Posted 23 Jul 2019

Clinical summary

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

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Neladenoson bialanate (BAY1067197) (5 mg)	Experimental	Drug: Neladenoson bialanate (BAY1067197)Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197) (10 mg)	Experimental	Drug: Neladenoson bialanate (BAY1067197)Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197) (20 mg)	Experimental	Drug: Neladenoson bialanate (BAY1067197)Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197) (30 mg)	Experimental	Drug: Neladenoson bialanate (BAY1067197)Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197) (40 mg)	Experimental	Drug: Neladenoson bialanate (BAY1067197)Chronic heart failure with preserved ejection fraction
Placebo	Placebo comparator	Drug: PlaceboChronic heart failure with preserved ejection fraction

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men or women aged 45 years and older
Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP

Key exclusion criteria (3 listed)

Acute decompensated heart failure within the past 4 weeks
Inability to exercise
Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF < 40%)

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
Neladenoson bialanate (BAY1067197)5 mg orally once daily for 20 weeks	Drug	Neladenoson bialanate (BAY1067197) (5 mg)
Neladenoson bialanate (BAY1067197)10 mg orally once daily for 20 weeks	Drug	Neladenoson bialanate (BAY1067197) (10 mg)
Neladenoson bialanate (BAY1067197)20 mg orally once daily for 20 weeks	Drug	Neladenoson bialanate (BAY1067197) (20 mg)
Neladenoson bialanate (BAY1067197)30 mg orally once daily for 20 weeks	Drug	Neladenoson bialanate (BAY1067197) (30 mg)
Neladenoson bialanate (BAY1067197)40 mg orally once daily for 20 weeks	Drug	Neladenoson bialanate (BAY1067197) (40 mg)
PlaceboOrally once daily for 20 weeks	Drug	Placebo

Primary outcome

Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
Time frame: Baseline, and up to 20 weeks of treatment
The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.

4 secondary outcomes

Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity
Time frame: Baseline, and up to 20 weeks of treatment
Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks
Time frame: Baseline, and up to 20 weeks of treatment
Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks
Time frame: Baseline, and up to 20 weeks of treatment
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
Time frame: Baseline, and up to 20 weeks of treatment

Results and safety

Results posted to the registry on 23 Jul 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
Placebo	76	70
Neladenoson Bialanate 5 mg	27	25
Neladenoson Bialanate 10 mg	50	46
Neladenoson Bialanate 20 mg	51	46
Neladenoson Bialanate 30 mg	50	41
Neladenoson Bialanate 40 mg	51	47

Primary outcome: Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment

Time frame: Baseline, and up to 20 weeks of treatment. Mean (Standard Deviation). Unit: meter

Measure	Placebo n = 65	Neladenoson Bialanate 5 mg n = 22	Neladenoson Bialanate 10 mg n = 44	Neladenoson Bialanate 20 mg n = 41	Neladenoson Bialanate 30 mg n = 34	Neladenoson Bialanate 40 mg n = 37
Value at baseline	329 (95)	306 (117)	300 (109)	328 (105)	321 (101)	363 (83)
Change from baseline to Week 20	1.89 (49.5)	24.8 (72.4)	27.2 (90.0)	14.6 (54.1)	16.3 (55.4)	10.7 (60.2)

Placebo vs Neladenoson Bialanate 5 mg vs Neladenoson Bialanate 10 mg vs Neladenoson Bialanate 20 mg vs Neladenoson Bialanate 30 mg vs Neladenoson Bialanate 40 mg: p = 0.5183, MCP-Mod method
Placebo vs Neladenoson Bialanate 5 mg vs Neladenoson Bialanate 10 mg vs Neladenoson Bialanate 20 mg vs Neladenoson Bialanate 30 mg vs Neladenoson Bialanate 40 mg: p = 0.3300, MCP-Mod method
Placebo vs Neladenoson Bialanate 5 mg vs Neladenoson Bialanate 10 mg vs Neladenoson Bialanate 20 mg vs Neladenoson Bialanate 30 mg vs Neladenoson Bialanate 40 mg: p = 0.6232, MCP-Mod method

Population analysed: Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure, and it also included subjects who were censored due to cardiovascular (CV) death or hospitalization for heart failure (HF) that prevented assessment of efficacy at 20 weeks.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study drug administration up to 26 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	21 of 76 (27.6%)	24 of 76 (31.6%)	2 of 76
Neladenoson Bialanate 5mg	9 of 27 (33.3%)	13 of 27 (48.1%)	0 of 27
Neladenoson Bialanate 10mg	11 of 50 (22%)	14 of 50 (28%)	2 of 50
Neladenoson Bialanate 20mg	11 of 51 (21.6%)	22 of 51 (43.1%)	1 of 51
Neladenoson Bialanate 30mg	14 of 50 (28%)	17 of 50 (34%)	1 of 50
Neladenoson Bialanate 40mg	16 of 51 (31.4%)	24 of 51 (47.1%)	1 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31162568Shah SJ, Voors AA, McMurray JJV, Kitzman DW, Viethen T, Bomfim Wirtz A, Huang E, Pap AF, Solomon SD. Effect of Neladenoson Bialanate on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2101-2112. doi: 10.1001/jama.2019.6717.

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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.

Bayer Study Director study director

Bayer

76 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neladenoson bialanate (BAY1067197) in people with Heart Failure, run by Bayer at 76 sites in 12 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 2 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Japan, Spain, Israel, Italy, Poland and 7 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. 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 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 23 Jul 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?

Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment (time frame: Baseline, and up to 20 weeks of treatment). 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 NCT03098979, 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 23 Jul 2019.