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Single Dose Escalation Study in Patients With Chronic Heart Failure

9. august 2016 opdateret af: Bayer

Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of a Single Oral Dose of BAY60-4552 in Patients With Biventricular Chronic Heart Failure and Pulmonary Hypertension in a Non-randomized, Non-blinded, Dose Escalation Design.

This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design. Furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. Several measurements will be performed to test how good the drug works and wether there are any unwanted reactions to the drug (e.g. blood tests, ECG, heart rate, blood pressure, adverse events). After a observation period the patient will be discharged from the hospital.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Hessen
      • Bad Nauheim, Hessen, Tyskland, 61231
      • Gießen, Hessen, Tyskland, 35392

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters

Exclusion Criteria:

  • Acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, severe valvular disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BAY60-4552, 1 mg
Subjects were planned to receive 1 mg of BAY60-4552 as solution
Medicin: BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Eksperimentel: BAY60-4552, 2.5 mg
Subjects were planned to receive 2.5 mg of BAY60-4552 as tablet
Medicin: BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Eksperimentel: BAY60-4552, 5 mg
Subjects were planned to receive 5.0 mg of BAY60-4552 as tablet
Medicin: BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Eksperimentel: BAY60-4552, 7.5 mg
Subjects were planned to receive 7.5 mg of BAY60-4552 as tablet
Medicin: BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Eksperimentel: BAY60-4552, 10 mg
Subjects were planned to receive 10 mg of BAY60-4552 as tablet
Medicin: BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in pulmonary capillary wedge pressure
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Change in mean pulmonary artery pressure
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
AUC
Tidsramme: Pre-dose and up to 72 hr post-dose
Area under the plasma concentration vs time curve from zero to infinity after single dose
Pre-dose and up to 72 hr post-dose
AUC/D
Tidsramme: Pre-dose and up to 72 hr post-dose
AUC divided by dose (mg)
Pre-dose and up to 72 hr post-dose
Cmax
Tidsramme: Pre-dose and up to 72 hr post-dose
Maximum drug concentration in plasma after single dose administration
Pre-dose and up to 72 hr post-dose
Cmax/D
Tidsramme: Pre-dose and up to 72 hr post-dose
Cmax divided by dose (mg)
Pre-dose and up to 72 hr post-dose
Number of participants with adverse events
Tidsramme: Approximately 2 weeks
Approximately 2 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean right atrial pressure
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Systolic pulmonary artery pressure
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Diastolic pulmonary artery pressure
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Heart rate
Tidsramme: At pre-study visit, pre-dose and up to 24 hr post-dose
At pre-study visit, pre-dose and up to 24 hr post-dose
Cardiac output
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Pulmonary vascular resistance
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Pulmonary vascular resistance index
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Systemic vascular resistance
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Systemic vascular resistance index
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Cardiac index
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Mean arterial pressure
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Systemic blood pressure
Tidsramme: At pre-study visit, pre-dose and up to 24 hr post-dose
At pre-study visit, pre-dose and up to 24 hr post-dose
Diastolic blood pressure
Tidsramme: At pre-study visit, pre-dose and up to 24 hr post-dose
At pre-study visit, pre-dose and up to 24 hr post-dose
Dyspnea Score
Tidsramme: Pre-dose and up to 48 hr post-dose
Subject is asked unpersuasively about his/her well-being in comparison to the baseline condition, measured on a 7-point Likert scale.
Pre-dose and up to 48 hr post-dose
AUC(0-6)
Tidsramme: Pre-dose and up to 6 hr post-dose
AUC from time 0 to 6 h after study drug intake
Pre-dose and up to 6 hr post-dose
AUCnorm
Tidsramme: Pre-dose and up to 72 hr post-dose
AUC divided by dose (mg) per kg body weight
Pre-dose and up to 72 hr post-dose
AUC(0-tn)
Tidsramme: Pre-dose and up to 72 hr post-dose
AUC from time 0 to the last data point
Pre-dose and up to 72 hr post-dose
AUC(0-tn)norm
Tidsramme: Pre-dose and up to 72 hr post-dose
AUC(0-tn) divided by dose (mg) per kg body weight
Pre-dose and up to 72 hr post-dose
Cmax,norm
Tidsramme: Pre-dose and up to 72 hr post-dose
Cmax divided by dose (mg) per kg body weight
Pre-dose and up to 72 hr post-dose
tmax
Tidsramme: Pre-dose and up to 72 hr post-dose
Time to reach maximum drug concentration in plasma after single dose
Pre-dose and up to 72 hr post-dose
t½
Tidsramme: Pre-dose and up to 72 hr post-dose
Half-life associated with the terminal slope
Pre-dose and up to 72 hr post-dose
Mean residence time
Tidsramme: Pre-dose and up to 72 hr post-dose
Pre-dose and up to 72 hr post-dose
Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
Tidsramme: Pre-dose and up to 72 hr post-dose
Pre-dose and up to 72 hr post-dose
Apparent volume of distribution associated with the terminal phase (after oral administration)
Tidsramme: Pre-dose and up to 72 hr post-dose
Pre-dose and up to 72 hr post-dose
Amount of drug excreted via urine
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Percent amount of drug excreted via urine
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Renal clearance of drug
Tidsramme: Pre-dose and up to 6 hr post-dose
Pre-dose and up to 6 hr post-dose
Renin activity
Tidsramme: Pre-dose and up to 24 hr post-dose
Pre-dose and up to 24 hr post-dose
Change from baseline of noradrenaline after drug administration
Tidsramme: Pre-dose and up to 24 hr post-dose
Pre-dose and up to 24 hr post-dose
N-terminal pro-atrial natriuretic peptide
Tidsramme: Pre-dose and up to 24 hr post-dose
Pre-dose and up to 24 hr post-dose
NT-pro B-type natriuretic peptide
Tidsramme: Pre-dose and up to 24 hr post-dose
Pre-dose and up to 24 hr post-dose
Big endothelin-1
Tidsramme: Pre-dose and up to 24 hr post-dose
Pre-dose and up to 24 hr post-dose
Cystatin C
Tidsramme: Pre-dose and up to 24 hr post-dose
Pre-dose and up to 24 hr post-dose
Change from baseline of osteopontin after drug administration
Tidsramme: Pre-dose and up to 24 hr post-dose
Pre-dose and up to 24 hr post-dose
Cyclic guanosine mono-phosphate
Tidsramme: Pre-dose and up to 24 hr post-dose
Pre-dose and up to 24 hr post-dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • Acute hemodynamic response to single oral doses of BAY 60-4552, a soluble guanylate cyclase stimulator, in patients with biventricular heart failure. V Mitrovic, B Swidnicki, A Ghofrani, W Mück, N Kirschbaum, J Mittendorf, J-P Stasch, G Wensing, R Frey, S Lentini. BMC Pharmacology 2009; 9(Suppl 1): P51.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2007

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

31. oktober 2007

Først indsendt, der opfyldte QC-kriterier

29. november 2007

Først opslået (Skøn)

30. november 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12356
  • 2007-003216-54 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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