stop_circleTerminated/Withdrawn

Heart Failure, Heart Decompensation

Bayer Identifier:

14836

ClinicalTrials.gov Identifier:

NCT01064037

EudraCT Number:

2009-017082-39

EU CT Number:

Not Available
A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects with Acute Decompensated Chronic Congestive Heart Failure (ADHF)

Trial purpose

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with a hysterectomy
    - Subjects must have the clinical diagnosis of congestive heart failure (CHF) made at least three months prior to enrollment
    - Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload
  • - Acute de-novo heart failure
    - Acute myocardial infarction and/or myocardial infarction within 30 days
    - Valvular heart disease requiring surgical intervention during the course of the study
    - Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
    - Primary hypertrophic cardiomyopathy
    - Acute inflammatory heart disease, eg, acute myocarditis
    - Unstable angina requiring angiography

Trial summary

Enrollment Goal
62
Trial Dates
April 2010 - March 2011
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Cinaciguat (BAY58-2667)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Terminated
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Terminated
Northampton General HospitalNorthampton, NN1 5BD, United Kingdom
Terminated
Dorrington Medical AssociatesHouston, 77030, United States
Terminated
Northwestern Memorial HospitalChicago, 60610, United States
Terminated
Chigasaki Tokushukai General HospitalChigasaki, 253-8558, Japan
Terminated
Shizuoka Tokushukai HospitalShizuoka, 421-0193, Japan
Completed
Minamiwakayama Medical CenterTanabe, 646-8558, Japan
Terminated
Kagoshima Medical CenterKagoshima, 892-0853, Japan
Terminated
Kanazawa Medical CenterKanazawa, 920-8650, Japan
Completed
A.O.U. di FerraraFerrara, 44100, Italy
Terminated
IRCCS San Raffaele PisanaRoma, 00192, Italy
Terminated
ASL 3 Genovese - LiguriaPontedecimo, 16164, Italy
Terminated
AUSL Lecce - PugliaCasarano, 73042, Italy
Completed
HELIOS Klinikum Erfurt GmbHErfurt, 99089, Germany
Completed
Asklepios Klinikum MelsungenMelsungen, 34212, Germany
Completed
Kliniken Maria Hilf GmbHMönchengladbach, 41063, Germany
Terminated
Northwick Park HospitalHarrow, HA1 3UJ, United Kingdom
Terminated
University of Cincinnati Hospital Health AllianceCincinnati, 45267, United States
Completed
Wayne State UniversityDetroit, 48201, United States
Terminated
Vanderbilt University Medical CenterNashville, 37232-7240, United States
Terminated
The Cleveland ClinicCleveland, 44195, United States
Completed
Hôpital Jeanne d'Arc - Dommartin-les-toulDOMMARTIN-LES-TOUL, 54201, France
Terminated
Centre Hospitalier Universitaire - PoitiersPOITIERS Cedex, 86021, France
Terminated
Institut de cardiologie/SalpétrièreParis cedex 13, 75013, France
Completed
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZBydgoszcz, 85-681, Poland
Completed
Szpital Specjalistyczny im. J. DietlaKrakow, 31-121, Poland
Terminated
Maria Cecilia Hospital SpACotignola, 48010, Italy
Terminated
Hospital de TorreviejaTorrevieja, 03186, Spain
Terminated
Hospital Universitario "Virgen de la Arrixaca"El Palmar, 30120, Spain
Completed
Kuils River HospitalKuils River, 7580, South Africa
Terminated
Clinical Projects Research SAWorcester, 6850, South Africa
Completed
Union HospitalJohannesburg, 1449, South Africa
Completed
Facultni nemocnice BrnoBrno, 625 00, Czech Republic
Terminated
Kaplan Medical CenterRehovot, 76100, Israel
Completed
Ziv Medical CenterSafed, 13100, Israel
Terminated
Western Galille Hospital NahariyaNahariya, Israel
Completed
Rambam Medical CenterHaifa, 31096, Israel
Terminated
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Terminated
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Terminated
Portiuncula HospitalBallinasloe, Ireland
Terminated
St Vincents University HospitalDublin, DUBLIN 4, Ireland
Completed
ZOZ MSWiA z Warminsko-Mazurskim Centrum OnkologiiOlsztyn, 10-228, Poland
Completed
109 Szpital Wojskowy z przychodnia SPZOZSzczecin, 70-965, Poland
Terminated
National Hospital Organization Shizuoka Medical CenterSunto, 411-8611, Japan
Terminated
Matsumoto Medical Center Matsumoto HospitalMatsumoto, 399-8701, Japan
Terminated
A.O.U. Policlinico ConsorzialeBari, 70124, Italy
Terminated
A.O. di PadovaPadova, 35128, Italy
Terminated
A.O.U. Policlinico Umberto IRoma, 00161, Italy
Completed
Hospital Universitario Clinica Puerta de HierroMajadahonda, 28222, Spain
Terminated
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Terminated
Olivedale ClinicJohannesburg, 2194, South Africa
Terminated
Fakultni nemocnice MotolPraha 5, 15006, Czech Republic
Terminated
Fakultni nemocnice Kralovske VinohradyPraha 10, 10034, Czech Republic
Completed
Nemocnice na HomolcePraha 5, 15030, Czech Republic
Terminated
Regional Hospital PardubicePardubice, 532 03, Czech Republic
Completed
St James' HospitalDublin, 8, Ireland
Terminated
Hopital LavalQuebec, G1V 4G5, Canada
Terminated
University of CalgaryCalgary, T2N 4Z6, Canada
Terminated
Vancouver General HospitalVancouver, V5Z 1M9, Canada
Completed
Szent Istvan HospitalBudapest, H-1096, Hungary
Completed
Gottsegen Gyorgy National Cardiology InstituteBudapest, 1096, Hungary
Terminated
Bacs-Kiskun Country HospitalKecskemet, 6000, Hungary
Terminated
Fejer megyei Szent Gyorgy KorhazSzekesfehervar, 8000, Hungary
Completed
Budai Irgalmasrendi HospitalBudapest, 1027, Hungary
Completed
Jyväskylä, Finland
Completed
Turku, Finland
Terminated
Hôtel DieuParis Cedex 04, 75181, France
Terminated
Kliniken Nord und SüdNürnberg, 90471, Germany
Terminated
Hôpital Lariboisière - ParisPARIS, 75475, France

Primary Outcome

  • Dyspnea VAS (using a visual analogue scale)
    date_rangeTime Frame:
    8 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Dyspnea assessment (Likert Scale)
    date_rangeTime Frame:
    up to follow-up (30 - 35 days)
    enhanced_encryption
    Safety Issue:
    no
  • Overall health status assessment (EQ-5D)
    date_rangeTime Frame:
    up to follow-up (30 - 35 days)
    enhanced_encryption
    Safety Issue:
    no
  • Changes in the dyspnea VAS at other time points
    date_rangeTime Frame:
    Up to follow up visit
    enhanced_encryption
    Safety Issue:
    No
  • Dyspnea assessment through Likert scale
    date_rangeTime Frame:
    Up to follow up visit
    enhanced_encryption
    Safety Issue:
    No
  • Overall health status assessment through EQ-5D Health Questionnaire
    date_rangeTime Frame:
    Up to the follow-up visit
    enhanced_encryption
    Safety Issue:
    No
  • Global clinical assessment by the physician
    date_rangeTime Frame:
    At 8, 24, and 48 hours
    enhanced_encryption
    Safety Issue:
    No
  • Change in concomitant medications
    date_rangeTime Frame:
    During the treatment
    enhanced_encryption
    Safety Issue:
    No
  • Safety variables
    Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment
    date_rangeTime Frame:
    Up to end of study
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects with Acute Decompensated Chronic Congestive Heart Failure (ADHF) within 12 hours after hospital admission (Pulmonary Artery Catheter eg, Swan-Ganz not required)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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