Phase
Condition
Pulmonary Arterial Hypertension
Stress
Vascular Diseases
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female patients aged 18 to 75 years.
- Patients with symptomatic PAH with a pulmonary vascular resistance (PVR) > 400dynseccm-5, mean pulmonary artery pressure ≥ 25 mmHg, and pulmonary capillary wedgepressure (PCWP) ≤ 15 mmHg as assessed by the most recent right heart catheterization (RHC) from medical history prior to screening to confirm the diagnosis. Alternatively,PCWP can be replaced by left ventricular end-diastolic pressure (≤ 15 mmHg). PAH ofthe following types:
- Idiopathic
- Hereditary
- Drug and toxin induced PAH
- Associated with PAH due to:
- Connective tissue disease (CTD)
- Congenital heart disease, but only if the patient underwent surgical repairmore than one year before enrolment
- Portal hypertension with liver cirrhosis (Note: patients with clinicalrelevant hepatic dysfunction are excluded; see exclusions related todisorders in organ function)
- Patients who are on stable doses of a PDE-5i and ERA combination therapy or on stablePDE-5i monotherapy 6 weeks prior to and at randomization but not at treatment goal (tadalafil 20 to 40 mg once daily or sildenafil at least 60 mg daily dose).
- WHO FC III at screening and at randomization.
- 6MWD test between 165 m and 440 m at screening and at randomization.
- Stable dose of diuretics, if used, for at least 30 days prior to and at randomization.
- Patients who are able to understand and follow instructions and who are able toparticipate in the study for the entire study.
- Women of childbearing potential must agree to use adequate contraception when sexuallyactive. Adequate contraception is defined as any combination of at least 2 effectivemethods of birth control, of which at least 1 is a physical barrier (e.g. condom withhormonal contraception like implants or combined oral contraceptives, condom withintrauterine devices). This applies beginning with signing of the informed consentform until 30 (+5) days after the last administration of study drug.
- Patients must have given their written informed consent to participate in the studyafter having received adequate previous information and prior to any study-specificprocedures.
Exclusion
Exclusion Criteria:
- Participation in another interventional clinical study within 30 days prior toscreening.
- All types of PH (including PH-IIP) except subtypes of Dana Point Group I specified inthe inclusion criteria.
- Previous treatment with riociguat.
- Pregnant women (i.e., positive serum ß-human-chorionic-gonadotropin test or othersigns of pregnancy), or breast feeding women, or women with childbearing potential notusing a combination of 2 effective contraception methods (as laid out in inclusioncriterion) throughout the study.
- Patients with a medical disorder, condition, or history of such that would impair thepatient's ability to participate or complete this study, in the opinion of theinvestigator.
- Relevant obstructive and restrictive or other lung diseases.
- Patients with underlying medical disorders with an anticipated life expectancy below 2years (e.g., active cancer disease with localized and/or metastasized tumor mass).
- Cardiovascular exclusion criteria like left ventricular disease, coronary heartdisease or stroke within previous 3 months.
- Patients with hypersensitivity to the investigational drug or any of the excipients.
- Patients unable to perform a valid 6MWD test (e.g., orthopedic disease, peripheralartery occlusive disease, which affects the patient's ability to walk). Note:Patients, who require walking aids, may be included if in the opinion of theinvestigator the walking distance is not impaired. Patients with a variance of morethan 15% between the screening and the randomization (i.e., baseline) 6MWD test.
Study Design
Study Description
Connect with a study center
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Camperdown, New South Wales 2050
AustraliaSite Not Available
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Chermside, Queensland 4032
AustraliaSite Not Available
Graz, 8036
AustriaSite Not Available
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Innsbruck, 6020
AustriaSite Not Available
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Wien, 1090
AustriaSite Not Available
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Bruxelles - Brussel, 1070
BelgiumSite Not Available
Leuven, 3000
BelgiumSite Not Available
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Brasília, Distrito Federal 70840 901
BrazilSite Not Available
Belo Horizonte, Minas Gerais 30441-070
BrazilSite Not Available
Porto Alegre, Rio Grande Do Sul 90050-170
BrazilSite Not Available
Blumenal, Santa Catarina 89030-101
BrazilSite Not Available
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Rio de Janeiro, 21949 900
BrazilSite Not Available
Sao Paulo, 05403-000
BrazilSite Not Available
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Calgary, Alberta T1Y 6J4
CanadaSite Not Available
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Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
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Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
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Toronto, Ontario M5G 2N2
CanadaSite Not Available
Montreal, Quebec H3T 1E2
CanadaSite Not Available
Praha 2, 12808
CzechiaSite Not Available
Praha 4, 140 21
CzechiaSite Not Available
Aarhus N, 8200
DenmarkSite Not Available
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København Ø, 2100
DenmarkSite Not Available
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Besancon, 25030
FranceSite Not Available
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GRENOBLE Cedex 09, 38043
FranceSite Not Available
Le Kremlin-Bicêtre, 94270
FranceSite Not Available
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Lille Cedex, 59037
FranceSite Not Available
Rouen, 76031
FranceSite Not Available
Heidelberg, Baden-Württemberg 69126
GermanySite Not Available
München, Bayern 81377
GermanySite Not Available
Würzburg, Bayern 97074
GermanySite Not Available
Hannover, Niedersachsen 30625
GermanySite Not Available
Köln, Nordrhein-Westfalen 50937
GermanySite Not Available
Homburg, Saarland 66421
GermanySite Not Available
Dresden, Sachsen 01307
GermanySite Not Available
Leipzig, Sachsen 04103
GermanySite Not Available
Lübeck, Schleswig-Holstein 23538
GermanySite Not Available
Berlin, 14050
GermanySite Not Available
Gießen, 35390
GermanySite Not Available
Hamburg, 20246
GermanySite Not Available
Chaidari, 124 62
GreeceSite Not Available
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Haidari, 124 62
GreeceSite Not Available
Thessaloniki, 546 36
GreeceSite Not Available
Napoli, Campania 80131
ItalySite Not Available
Roma, Lazio 00161
ItalySite Not Available
Pavia, Lombardia 27100
ItalySite Not Available
Palermo, Sicilia 90127
ItalySite Not Available
Nagoya, Aichi 467-8602
JapanSite Not Available
Sendai, Miyagi 980-8574
JapanSite Not Available
Bunkyo-ku, Tokyo 113-8655
JapanSite Not Available
Seoul, 135-710
Korea, Republic ofSite Not Available
Culiacan, Sinaloa 80020
MexicoSite Not Available
Mexico D.F., 14080
MexicoSite Not Available
Amsterdam, 1081 HV
NetherlandsSite Not Available
Nijmegen, 6500HB
NetherlandsSite Not Available
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Lodz, 91-347
PolandSite Not Available
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Otwock, 05-400
PolandSite Not Available
Wroclaw, 51-124
PolandSite Not Available
Almada, Lisboa 2801-951
PortugalSite Not Available
Coimbra, 3000-075
PortugalSite Not Available
Lisboa, 1649-035
PortugalSite Not Available
Las Palmas de Gran Canaria, Las Palmas 35020
SpainSite Not Available
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La Laguna, Santa Cruz de Tenerife 38320
SpainSite Not Available
Barcelona, 08035
SpainSite Not Available
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Madrid, 28041
SpainSite Not Available
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Salamanca, 37007
SpainSite Not Available
Toledo, 45004
SpainSite Not Available
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Genève, 1205
SwitzerlandSite Not Available
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Zürich, 8091
SwitzerlandSite Not Available
Kaoshiung, 81346
TaiwanSite Not Available
Tainan, 704
TaiwanSite Not Available
Taipei, 10016
TaiwanSite Not Available
Ankara, 06100
TurkeySite Not Available
Istanbul, 34093
TurkeySite Not Available
Izmir, 34098
TurkeySite Not Available
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Cambridge, Cambridgeshire CB23 3RE
United KingdomSite Not Available
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Bath, Somerset BA1 3NG
United KingdomSite Not Available
Clydebank, West Dunbartonshire G81 4DY
United KingdomSite Not Available
London, SW3 6NP
United KingdomSite Not Available
Sheffield, S10 2JF
United KingdomSite Not Available
Phoenix, Arizona 85012
United StatesSite Not Available
Tucson, Arizona 85724
United StatesSite Not Available
Sacramento, California 95817
United StatesSite Not Available
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New Haven, Connecticut 06520
United StatesSite Not Available
Orlando, Florida 32803
United StatesSite Not Available
Weston, Florida 33331
United StatesSite Not Available
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Chicago, Illinois 60612
United StatesSite Not Available
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Oak Lawn, Illinois 60453
United StatesSite Not Available
Kansas City, Kansas 66103
United StatesSite Not Available
Louisville, Kentucky 40202
United StatesSite Not Available
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Boston, Massachusetts 02114-2696
United StatesSite Not Available
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Ann Arbor, Michigan 48109-0330
United StatesSite Not Available
Detroit, Michigan 48202
United StatesSite Not Available
Troy, Michigan 48085
United StatesSite Not Available
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Saint Louis, Missouri 63110
United StatesSite Not Available
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St, Louis, Missouri 63110
United StatesSite Not Available
Newark, New Jersey 07112
United StatesSite Not Available
Mineola, New York 11501
United StatesSite Not Available
New York, New York 10003
United StatesSite Not Available
Rochester, New York 14623
United StatesSite Not Available
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Chapel Hill, North Carolina 27599
United StatesSite Not Available
Cleveland, Ohio 44195
United StatesSite Not Available
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Columbus, Ohio 43210-1240
United StatesSite Not Available
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Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Nashville, Tennessee 37232
United StatesSite Not Available
Dallas, Texas 75390
United StatesSite Not Available
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Falls Church, Virginia 22042
United StatesSite Not Available
Richmond, Virginia 23225
United StatesSite Not Available
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Seattle, Washington 98195
United StatesSite Not Available
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Milwaukee, Wisconsin 53215
United StatesSite Not Available
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