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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.

Base di dati: BASEC (Importata da 19.04.2024), WHO (Importata da 18.04.2024)
Cambiato: 23 dic 2023, 16:39
Categoria di malattie: Malattie arteriose e venose incluse la trombosi venosa profonda e l'embolia polmonare

Descrizione riassuntiva della sperimentazione (Fonte di dati: 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.

Malattie studiate(Fonte di dati: BASEC)

Lungenhochdruck (pulmonale arterielle Hypertonie, PAH)

Health conditions (Fonte di dati: WHO)

Pulmonary Arterial Hypertension

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: BASEC)

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

Interventions (Fonte di dati: WHO)

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

Criteri per la partecipazione alla sperimentazione (Fonte di dati: 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

Criteri di esclusione (Fonte di dati: 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 (Fonte di dati: 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.

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/show/NCT02891850

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02891850
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

26 ago 2016

Inserimento del primo partecipante

11 gen 2017

Stato di reclutamento

Completed

Titolo scientifico (Fonte di dati: 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

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

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

Fase (Fonte di dati: WHO)

Phase 4

Punti finali primari (Fonte di dati: WHO)

Efficacy (Y/N)

Punti finali secondari (Fonte di dati: 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

Contatto per informazioni (Fonte di dati: WHO)

Please refer to primary and secondary sponsors

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

Ginevra, Zurigo

Paesi di esecuzione (Fonte di dati: 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

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

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

Contatto per informazioni generali (Fonte di dati: WHO)

Bayer Study Director
Bayer

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Bayer Study Director
Bayer

Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)

Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)

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

Data di autorizzazione da parte della commissione d’etica

13.04.2017

Altri numeri di identificazione delle sperimentazioni

Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID) (Fonte di dati: BASEC)

2017-00035

Secondary ID (Fonte di dati: WHO)

2016-001067-36
18588
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