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)

Heart Failure Clinical Trial

— COMPOSE EARLY  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01064037
• Other study ID #: 14836
• Secondary ID: 2009-017082-39
• Status: Terminated
• Phase: Phase 2
• First received: February 4, 2010
• Last updated: September 23, 2015
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: German Institute of Medical Documentation and InformationIsrael: Ministry of HealthItaly: The Italian Medicines AgencyJapan: National Institute of Health SciencesKorea: Food and Drug AdministrationHungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Spanish Agency of MedicinesSouth Africa: Human Research Ethics CommitteePoland: Ministry of HealthCzech Republic: State Institute for Drug ControlIreland: Irish Medicines BoardUnited 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: 62
• Est. completion date: March 2011
• Est. primary completion date: February 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 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

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

• Heart Decompensation
• 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 during 48h

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea VAS (using a visual analogue scale)		8 hours	No
Secondary	Dyspnea assessment (Likert Scale)		up to follow-up (30 - 35 days)	No
Secondary	Overall health status assessment (EQ-5D)		up to follow-up (30 - 35 days)	No
Secondary	Changes in the dyspnea VAS at other time points		Up to follow up visit	No
Secondary	Dyspnea assessment through Likert scale		Up to follow up visit	No
Secondary	Overall health status assessment through EQ-5D Health Questionnaire		Up to the follow-up visit	No
Secondary	Global clinical assessment by the physician		At 8, 24, and 48 hours	No
Secondary	Change in concomitant medications		During the treatment	No
Secondary	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	Up to end of study	Yes

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