BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

Acute Heart Failure Clinical Trial

— COMPOSE 1  

Official title:

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01065077
• Other study ID #: 14560
• Secondary ID: 2009-014377-40
• Status: Terminated
• Phase: Phase 2
• First received: February 8, 2010
• Last updated: September 23, 2015
• Start date: March 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesIsrael: Ministry of HealthJapan: Pharmaceuticals and Medical Devices AgencyCroatia: Agency for Medicinal Product and Medical DevicesRussia: FSI Scientific Center of Expertise of Medical ApplicationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovenia: Agency for Medicinal Products - Ministry of HealthThailand: Food and Drug AdministrationUnited States: Food and Drug AdministrationItaly: The Italian Medicines AgencyRomania: National Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlSwitzerland: SwissmedicSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ovariectomy, and women with a hysterectomy

• Subjects must have the clinical diagnosis of 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Cinaciguat (BAY58-2667)
Infusion of 150 µg/h during 48h
• Cinaciguat (BAY58-2667)
Infusion of 100 µg/h during 48h
• Cinaciguat (BAY58-2667)
Infusion of 50 µg/h during 48h
• Placebo
Infusion of placebo during 48h

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Austria,  Croatia,  Finland,  Germany,  Israel,  Italy,  Japan,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Sweden,  Switzerland,  Thailand, 

References & Publications (1)

Gheorghiade M, Greene SJ, Filippatos G, Erdmann E, Ferrari R, Levy PD, Maggioni A, Nowack C, Mebazaa A; COMPOSE Investigators and Coordinators. Cinaciguat, a soluble guanylate cyclase activator: results from the randomized, controlled, phase IIb COMPOSE p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Capillary Wedge Pressure		8 hours	No
Secondary	Cardiac index (CI)		8 hours and 48 hours	No
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)		Follow up (30 + 5 days)	No
Secondary	Right atrial pressure (RAP)		8 hours and 48 hours	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find information about studies related to Bayer Healthcare products conducted in Europe
•   Click here to find results for studies related to Bayer Healthcare products.