Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Efficacy and Safety of Upfront Combination of ΒΟsentan and ΤΑdalafil in Pulmonary Arterial Hypertension (BOTA-PAH)

24. januar 2018 oppdatert av: Elpen Pharmaceutical Co. Inc.

An Observational, Non-interventional, Multicenter Study to Evaluate the Efficacy and Safety of Upfront Combination of Bosentan and Tadalafil in Pulmonary Arterial Hypertension in Greek Patients

The development of disease-targeted drugs for the treatment of pulmonary arterial hypertension (PAH) has significantly improved within the last years. Combining drug products with different mechanisms of action such as Endothelin-Receptor-Antagonists (ERAs) and Phosphodiesterase-Type-5-inhibitors (PDE-5-Inhibitors) has become increasingly important for the treatment of PAH. Recently, the results of the AMBITION study reported that an upfront combination treatment of ambrisentan and tadalafil immediately after diagnosis leads to a delayed disease progression. On the other hand, the sequential combination of bosentan and sildenafil did not show a similar positive clinical effect and this was attributed to a negative clinically relevant pharmacodynamic drug-drug interaction. Although, recent guidelines have extrapolated that initial upfront combination treatment follows a class effect in terms of efficacy and safety, there is an imperative need to support this notion with other combinations of ERAs and PDE-5-Inhibitors.

Studieoversikt

Status

Tilbaketrukket

Forhold

Detaljert beskrivelse

The primary objective of BOTA study is to compare the change in clinical and hemodynamic measures of PAH after the initiation of first line combination therapy with bosentan and tadalafil in adult patients with PAH. The safety and tolerability of first line combination therapy will also be evaluated.

In patients with PAH initial upfront combination treatment with bosentan and tadalafil

  1. Improves

    • Exercise capacity as expressed by distance walked in six minute walk test and WHO functional class
    • Hemodynamics in terms of pulmonary vascular resistance (PVR), mean pulmonary artery pressure (mPAP) reduction and cardiac index (CI) elevation
    • Quality of life
    • NTproBNP serum levels
    • Echocardiographic prognostic parameters such as right atrial area and presence of pericardial effusion.

  2. Is safe as assessed by

    • Liver function markers such as serum SGOT and SGPT levels
    • Hemoglobin levels

Studietype

Observasjonsmessig

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Newly diagnosed patients with PAH

Beskrivelse

Inclusion Criteria:

Male or females between 18 to 75 years of age at inclusion

Diagnosis of PAH due to the following:

  • Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
  • Hereditary PAH
  • PAH secondary to connective tissue disease
  • PAH diagnosis confirmed by right heart catheterization performed within 3 months prior to study enrolment Subjects must weigh at least 40 kg at inclusion Subject must have a current diagnosis of being in World Health Organisation (WHO) Functional Class II or III.

Treatment PAH naïve subjects PAH documented by

  • mPAP ≥25mmHg,
  • pulmonary capillary wedge pressure (PCWP) or
  • left ventricular end-diastolic pressure (LVEDP) ≤15mmHg and
  • PVR ≥3 Wood Units. Subject must walk a distance of ≥125m and ≤500m at the screening visit

Exclusion Criteria:

  • History of pulmonary embolism
  • No prior treatment with PDE-5 inhibitors
  • History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
  • Current treatment with nitrates or nitric oxide
  • Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
  • History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Month 6
Tidsramme: 6 months
N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate marker of heart failure. The geometric mean ratio will be calculated as the ratio between the month 6 value and the Baseline value and presented as percent change = 100 * (geometric mean ratio - 1). The Baseline value is the last value prior to administration of study drug; this may be prior to or on the day of study drug initiation.
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With First Adjudicated Clinical Failure (CF) Event
Tidsramme: 6 months
Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Clinical Response
6 months
Time to first clinical worsening (TTCW) event
Tidsramme: 6 months
TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event.
6 months
Percentage of Participants With a Satisfactory Clinical Response at Month 6
Tidsramme: 6 months
A satisfactory clinical response at month 6 is defined as a participant who meets all of the following criteria: 10% improvement in 6MWD compared with Baseline;
6 months
Change From Baseline in the World Health Organization Functional Class at month 6
Tidsramme: 6 months
Change From Baseline in the World Health Organization Functional Class Time Frame: Baseline and Month 6 The WHO Functional Class (FC) indicates the severity of PAH and is an adaptation of the New York Heart Association classification.
6 months
Change From Baseline in the 6 Minute Walk Distance (6MWD) Test at month 6
Tidsramme: 6 months

Change From Baseline in the 6 Minute Walk Distance (6MWD) Test at month 6

MWD is the distance a participant can walk in 6 minutes. The 6-minute walk distance (6MWD) test measures the distance that a participant can walk in a period of 6 minutes.
6 months
Change From Baseline in Borg Dyspnea Index at month 6
Tidsramme: 6 months
Borg Dyspnea Index (BDI) indicates the degree of breathlessness after completion of the 6 minute walk test.
6 months
Quality of Life
Tidsramme: 6 moths
Change in emPHasis-10 questionnaire score
6 moths

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Elpen Pharmaceutical Co. Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. desember 2017

Primær fullføring (Forventet)

1. desember 2019

Studiet fullført (Forventet)

1. desember 2019

Datoer for studieregistrering

Først innsendt

28. april 2017

Først innsendt som oppfylte QC-kriteriene

2. mai 2017

Først lagt ut (Faktiske)

3. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. januar 2018

Sist bekreftet

1. august 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2017-BSN-EL-73

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Pulmonal hypertensjon

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Macedonia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere