A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

Acute Heart Failure Clinical Trial

— COMPOSE 2  

Official title:

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01067859
• Other study ID #: 14663
• Secondary ID: 2009-014378-16
• Status: Terminated
• Phase: Phase 2
• First received: February 11, 2010
• Last updated: September 23, 2015
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Philippines: Department of HealthBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentIreland: Irish Medicines BoardArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaMexico: Federal Commission for Sanitary Risks ProtectionUnited States: Food and Drug Administration
• 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: 5
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• 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 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

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 25 µg/h during 48 hours
• Cinaciguat (BAY58-2667)
Infusion of 10 µg/h during 48 hours
• Placebo
Infusion of placebo during 48 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  France,  Germany,  Ireland,  Mexico,  Philippines, 

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 (after 30+5 days)	No
Secondary	Right atrial pressure (RAP)		8 hours and 48 hours	No

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