Trial Condition(s):
Heart Failure
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) (COMPOSE EARLY)
Bayer Identifier:
14836
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Christian-Albrechts-Universität Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northampton General Hospital Northampton, United Kingdom, NN1 5BD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dorrington Medical Associates Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northwestern Memorial Hospital Chicago, United States, 60610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chigasaki Tokushukai General Hospital Chigasaki, Japan, 253-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Tokushukai Hospital Shizuoka, Japan, 421-0193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Minamiwakayama Medical Center Tanabe, Japan, 646-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kagoshima Medical Center Kagoshima, Japan, 892-0853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kanazawa Medical Center Kanazawa, Japan, 920-8650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Ferrara Ferrara, Italy, 44100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS San Raffaele Pisana Roma, Italy, 00192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL 3 Genovese - Liguria Pontedecimo, Italy, 16164 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Lecce - Puglia Casarano, Italy, 73042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HELIOS Klinikum Erfurt GmbH Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinikum Melsungen Melsungen, Germany, 34212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northwick Park Hospital Harrow, United Kingdom, HA1 3UJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Cincinnati Hospital Health Alliance Cincinnati, United States, 45267 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wayne State University Detroit, United States, 48201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vanderbilt University Medical Center Nashville, United States, 37232-7240 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Cleveland Clinic Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Jeanne d'Arc - Dommartin-les-toul DOMMARTIN-LES-TOUL, France, 54201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire - Poitiers POITIERS Cedex, France, 86021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut de cardiologie/Salpétrière Paris cedex 13, France, 75013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Bydgoszcz, Poland, 85-681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Specjalistyczny im. J. Dietla Krakow, Poland, 31-121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maria Cecilia Hospital SpA Cotignola, Italy, 48010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Torrevieja Torrevieja, Spain, 03186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "Virgen de la Arrixaca" El Palmar, Spain, 30120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kuils River Hospital Kuils River, South Africa, 7580 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Projects Research SA Worcester, South Africa, 6850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Union Hospital Johannesburg, South Africa, 1449 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Facultni nemocnice Brno Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaplan Medical Center Rehovot, Israel, 76100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziv Medical Center Safed, Israel, 13100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Western Galille Hospital Nahariya Nahariya, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Medical Center Haifa, Israel, 31096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Portiuncula Hospital Ballinasloe, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Vincents University Hospital Dublin, Ireland, DUBLIN 4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Olsztyn, Poland, 10-228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 109 Szpital Wojskowy z przychodnia SPZOZ Szczecin, Poland, 70-965 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Hospital Organization Shizuoka Medical Center Sunto, Japan, 411-8611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Matsumoto Medical Center Matsumoto Hospital Matsumoto, Japan, 399-8701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Consorziale Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Clinica Puerta de Hierro Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Olivedale Clinic Johannesburg, South Africa, 2194 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Motol Praha 5, Czech Republic, 15006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 10034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nemocnice na Homolce Praha 5, Czech Republic, 15030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Hospital Pardubice Pardubice, Czech Republic, 532 03 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St James' Hospital Dublin, Ireland, 8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Laval Quebec, Canada, G1V 4G5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Calgary Calgary, Canada, T2N 4Z6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vancouver General Hospital Vancouver, Canada, V5Z 1M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szent Istvan Hospital Budapest, Hungary, H-1096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gottsegen Gyorgy National Cardiology Institute Budapest, Hungary, 1096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bacs-Kiskun Country Hospital Kecskemet, Hungary, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fejer megyei Szent Gyorgy Korhaz Szekesfehervar, Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Budai Irgalmasrendi Hospital Budapest, Hungary, 1027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jyväskylä, Finland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôtel Dieu Paris Cedex 04, France, 75181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Nord und Süd Nürnberg, Germany, 90471 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Lariboisière - Paris PARIS, France, 75475 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Dyspnea VAS (using a visual analogue scale)Timeframe: 8 hours
Secondary Outcome
- Dyspnea assessment (Likert Scale)Timeframe: up to follow-up (30 - 35 days)
- Overall health status assessment (EQ-5D)Timeframe: up to follow-up (30 - 35 days)
- Changes in the dyspnea VAS at other time pointsTimeframe: Up to follow up visit
- Dyspnea assessment through Likert scaleTimeframe: Up to follow up visit
- Overall health status assessment through EQ-5D Health QuestionnaireTimeframe: Up to the follow-up visit
- Global clinical assessment by the physicianTimeframe: At 8, 24, and 48 hours
- Change in concomitant medicationsTimeframe: During the treatment
- Safety variablesFrequency 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 assessmentTimeframe: Up to end of study
Additional Information
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