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SNCTP000002114 | NCT02891850 | BASEC2017-00035

Riociguat als Ersatz der Therapie mit PDE-5 Hemmern im Vergleich zu fortgesetzter Therapie mit PDE-5 Hemmern.

Data source: BASEC (Imported from 25.04.2024), WHO (Imported from 25.04.2024)
Changed: Dec 23, 2023, 4:39 PM
Disease category: Arterial and venous diseases including deep venous thrombosis and lung embolism

Brief description of trial (Data source: BASEC)

Die Studie untersucht die Wirksamkeit von Riociguat bei Patienten mit Lungenhochdruck, deren bisherige Therapie mit sog. PDE-5 Hemmern ersetzt wird durch Riociguat. Patienten, die mit einer stabilen Dosierung eines PDE-5 Hemmers behandelt werdn, aber das Therapieziel nicht erreicht haben werden zufällig 2 Gruppen zugeteilt, die entweder gleich weiter therapiert oder aber auf Riociguat umgestellt werden. Danach wird in beiden Gruppen untersucht, wie weit eine zufriedenstellende Reaktion auf die Therapie erreicht wird.

Health conditions investigated(Data source: BASEC)

Lungenhochdruck (pulmonale arterielle Hypertonie, PAH)

Health conditions (Data source: WHO)

Pulmonary Arterial Hypertension

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Therapie mit Riociguat, zugelassen in der Schweiz untern dem Namen Adempas(r)

Interventions (Data source: WHO)

Drug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: Tadalafil

Criteria for participation in trial (Data source: BASEC)

-männliche und weibliche Patienten, 18 bis 75 Jahre
-eine bestimmte Form des Lungenhochdrucks (PAH)
-Vor der Behandlung in der Studie eine während 6 Wochen unveränderte Vorbehandlung entweder mit PDE-5 Inhibitoren alleine oder in Kombination mit sog. Endothelinrezeptorhemmern
-6-Minuten Gehtest von 165 bis 440 Meter
-schriftliche Einverständniserklärung

Exclusion criteria (Data source: BASEC)

-Teilnahme in anderer klinischer Studie innert 30 Tagen vor der Studie
-alle anderen Formen des Lungenhochdrucks, ausser PAH
-Vorbehandlung mit Riociguat / Adempas
-Schwangerschaft / Stillzeit
-Lungenerkrankungen
-gewisse Herzerkrankungen
-Krankheiten die die Durchführung des 6-Minuten-Gehtests verhindern

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Male and female patients aged 18 to 75 years.

- Patients with symptomatic PAH with a pulmonary vascular resistance (PVR) > 400
dyn*sec*cm-5, mean pulmonary artery pressure = 25 mmHg, and pulmonary capillary wedge
pressure (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 of
the 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 repair
more than one year before enrolment

- Portal hypertension with liver cirrhosis (Note: patients with clinical
relevant hepatic dysfunction are excluded; see exclusions related to
disorders in organ function)

- Patients who are on stable doses of a PDE-5i and ERA combination therapy or on stable
PDE-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 to
participate in the study for the entire study.

- Women of childbearing potential must agree to use adequate contraception when sexually
active. Adequate contraception is defined as any combination of at least 2 effective
methods of birth control, of which at least 1 is a physical barrier (e.g. condom with
hormonal contraception like implants or combined oral contraceptives, condom with
intrauterine devices). This applies beginning with signing of the informed consent
form until 30 (+5) days after the last administration of study drug.

- Patients must have given their written informed consent to participate in the study
after having received adequate previous information and prior to any study-specific
procedures.

Exclusion Criteria:

- Participation in another interventional clinical study within 30 days prior to
screening.

- All types of PH (including PH-IIP) except subtypes of Dana Point Group I specified in
the inclusion criteria.

- Previous treatment with riociguat.

- Pregnant women (i.e., positive serum ß-human-chorionic-gonadotropin test or other
signs of pregnancy), or breast feeding women, or women with childbearing potential not
using a combination of 2 effective contraception methods (as laid out in inclusion
criterion) throughout the study.

- Patients with a medical disorder, condition, or history of such that would impair the
patient's ability to participate or complete this study, in the opinion of the
investigator.

- Relevant obstructive and restrictive or other lung diseases.

- Patients with underlying medical disorders with an anticipated life expectancy below 2
years (e.g., active cancer disease with localized and/or metastasized tumor mass).

- Cardiovascular exclusion criteria like left ventricular disease, coronary heart
disease 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, peripheral
artery occlusive disease, which affects the patient's ability to walk). Note:
Patients, who require walking aids, may be included if in the opinion of the
investigator the walking distance is not impaired. Patients with a variance of more
than 15% between the screening and the randomization (i.e., baseline) 6MWD test.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02891850

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02891850
Further information on trial

Date trial registered

Aug 26, 2016

Incorporation of the first participant

Jan 11, 2017

Recruitment status

Completed

Academic title (Data source: WHO)

A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 4

Primary end point (Data source: WHO)

Efficacy (Y/N)

Secundary end point (Data source: WHO)

Change in 6 Minute Walking Distance (6MWD) from baseline to 24 weeks;Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 24 weeks;Change in World Health Organization Functional Class (WHO FC) from baseline to 24 weeks;Change in clinical worsening from baseline to 24 weeks

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Geneva, Zurich

Countries (Data source: WHO)

Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Republic of, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Simon Rotzler
+41 465 81 11
clinical.operations.switzerland@bayer.com

Contact for general information (Data source: WHO)

Bayer Study Director
Bayer

Contact for scientific information (Data source: WHO)

Bayer Study Director
Bayer

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Commission Cantonale d’éthique de la recherche Genève (CCER)

Date of authorisation by the ethics committee

13.04.2017

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2017-00035

Secondary ID (Data source: WHO)

2016-001067-36
18588
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