Hypertension, PulmonaryEASNCT01784562
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
A study testing Adempas (Riociguat, BAY63-2521) in people with Hypertension, Pulmonary, run by Bayer at 102 sites in 20 countries.
Trial summary
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Adempas (Riociguat, BAY63-2521)
- How many people
- Not given
- Where
- 102 sitesin 20 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery
Who cannot join
- All types of pulmonary hypertension other than Dana Point Classification Group 4
- Operable patients listed for PEA (Pulmonary Endarterectomy)
Trial locations and contacts
102 sites in 20 countries.
102 sites in 20 countries
United States24 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Aurora, Colorado, 80045
Study site
Baltimore, Maryland, 21201-1595
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02118
Study site
Chicago, Illinois, 60637
Study site
Cleveland, Ohio, 44195
Study site
Columbus, Ohio, 43221
Study site
Dallas, Texas, 75390
Study site
El Paso, Texas, 79902
Study site
Fairfield, Ohio, 45014
Study site
Houston, Texas, 77030
Study site
Iowa City, Iowa, 52242-1089
Study site
La Jolla, California, 92037
Study site
Los Angeles, California, 90073
Study site
New York, New York, 10032
Study site
Newark, New Jersey, 07112
Study site
Omaha, Nebraska, 68131
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pittsburgh, Pennsylvania, 15212
Study site
Providence, Rhode Island, 02903-4900
Study site
Sacramento, California, 95817
Study site
Tucson, Arizona, 85724
Study site
Weston, Florida, 33331
Germany12 sites
Study site
Cologne, North Rhine-Westphalia, 50924
Study site
Dresden, Saxony, 01307
Study site
Giessen, Hesse, 35392
Study site
Greifswald, Mecklenburg-Vorpommern, 17475
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20246
Study site
Hanover, Lower Saxony, 30625
Study site
Heidelberg, Baden-Wurttemberg, 69126
Study site
Homburg, Saarland, 66421
Study site
Leipzig, Saxony, 04103
Study site
München, Bavaria, 81377
Study site
Regensburg, Bavaria, 93042
Study site
Würzburg, Bavaria, 97074
France9 sites
Study site
Besançon, 25030
Study site
Brest, F-29609
Study site
Bron, 69500
Study site
Caen, 14033
Study site
Le Kremlin-Bicêtre, 94275
Study site
Montpellier, 34059
Study site
Pessac, 33604
Study site
Rouen, 76031
Study site
Vandœuvre-lès-Nancy, 54511
Turkey (Türkiye)6 sites
Study site
Ankara
Study site
Istanbul, 34-300
Study site
Istanbul, 34-390
Study site
Istanbul, 34304
Study site
Izmir, 34098
Study site
Izmir, 35100
Canada5 sites
Study site
Calgary, Alberta, T1Y 6J4
Study site
London, Ontario, N6C 2R5
Study site
Montreal, Quebec, H3T 1E2
Study site
Ottawa, Ontario, K1Y 4W7
Study site
Toronto, Ontario, M5G 2C4
Colombia5 sites
Study site
Bogotá, Bogota D.C.
Study site
Bogotá, Cundinamarca
Study site
Bogotá
Study site
Cali, Valle del Cauca Department
Study site
Santa Fé
Japan4 sites
Study site
Bunkyo-ku, Tokyo, 113-8655
Study site
Chiba, Chiba, 260-8677
Study site
Nagoya, Aichi-ken, 467-8602
Study site
Sendai, Miyagi, 980-8574
Portugal4 sites
Study site
Almada, 2801-951
Study site
Coimbra, Coimbra District, 3000-075
Study site
Lisbon, Lisbon District, 1649-035
Study site
Lisbon, 1169-024
Spain4 sites
Study site
Barcelona, Barcelona, 08035
Study site
Barcelona, Barcelona, 08036
Study site
Madrid, Madrid, 28041
Study site
Seville, Sevilla, 41013
Switzerland4 sites
Study site
Bern, Canton of Bern, 3010
Study site
Lausanne, Canton of Vaud, 1011
Study site
Sankt Gallen, Canton of St. Gallen, 9007
Study site
Zurich, Canton of Zurich, 8091
United Kingdom4 sites
Study site
Cambridge, Cambridgeshire, CB23 3RE
Study site
Glasgow, West Dunbartonshire, G81 4DY
Study site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Study site
Sheffield, South Yorkshire, S10 2JF
Austria3 sites
Study site
Graz, Styria, 8036
Study site
Innsbruck, Tyrol, 6020
Study site
Vienna, State of Vienna, 1090
Italy3 sites
Study site
Pavia, 27100
Study site
Roma, 00161
Study site
Trieste, 34149
Mexico3 sites
Study site
Mexico City, Mexico City, 14000
Study site
México D.F., Mexico City, 14080
Study site
Monterrey, Nuevo León, 64718
Netherlands3 sites
Study site
Amsterdam, 1081 HV
Study site
Nieuwegein, 3435 CM
Study site
Rotterdam, 3015 CE
Sweden3 sites
Study site
Linköping, 581 85
Study site
Lund, 221 85
Study site
Umeå, 901 85
Russia2 sites
Study site
Novosibirsk, 630055
Study site
Saint Petersburg, 197341
About this study
Official title: An Open-label Phase IIIb Study of Riociguat in Patients With In-operable CTEPH, or Recurrent or Persisting PH After Surgical Treatment Who Are Not Satisfactorily Treated and Cannot Participate in Any Other CTEPH Trial
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Adempas (Riociguat, BAY63-2521)
- Keywords
- Chronic thromboembolic pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adempas (Riociguat, BAY63-2521)Drug
Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784562
- Sponsor's protocol ID
- 16097
- Other IDs
- 2012-002104-40
- Acronym
- EAS
- Status last verified
- Jan 2016
- First submitted
- 4 Feb 2013
- Last updated
- 6 Jan 2016
- Results posted
- No
Publications
McLaughlin VV, Jansa P, Nielsen-Kudsk JE, Halank M, Simonneau G, Grunig E, Ulrich S, Rosenkranz S, Gomez Sanchez MA, Pulido T, Pepke-Zaba J, Barbera JA, Hoeper MM, Vachiery JL, Lang I, Carvalho F, Meier C, Mueller K, Nikkho S, D'Armini AM. Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm Med. 2017 Dec 28;17(1):216. doi: 10.1186/s12890-017-0563-7.
PubMed 29282032
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase IIIb Study of Riociguat in Patients With In-operable CTEPH, or Recurrent or Persisting PH After Surgical Treatment Who Are Not Satisfactorily Treated and Cannot Participate in Any Other CTEPH Trial
- ClinicalTrials.gov ID
- NCT01784562
- Acronym / sponsor ID
- EAS / 16097
- Conditions
- Hypertension, Pulmonary
- Keywords
- Chronic thromboembolic pulmonary hypertension
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery
Key exclusion criteria (2 listed)
- All types of pulmonary hypertension other than Dana Point Classification Group 4
- Operable patients listed for PEA (Pulmonary Endarterectomy)
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 |
|---|---|---|
| Adempas (Riociguat, BAY63-2521)Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Derived from this study: PubMed 29282032McLaughlin VV, Jansa P, Nielsen-Kudsk JE, Halank M, Simonneau G, Grunig E, Ulrich S, Rosenkranz S, Gomez Sanchez MA, Pulido T, Pepke-Zaba J, Barbera JA, Hoeper MM, Vachiery JL, Lang I, Carvalho F, Meier C, Mueller K, Nikkho S, D'Armini AM. Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm Med. 2017 Dec 28;17(1):216. doi: 10.1186/s12890-017-0563-7.
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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
102 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adempas (Riociguat, BAY63-2521) in people with Hypertension, Pulmonary, run by Bayer at 102 sites in 20 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in United States, Germany, France, Turkey (Türkiye), Canada and 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01784562, 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 6 Jan 2016.